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U.S. Department of Health and Human Services

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FDA Enforcement Report For February 11, 2009

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

 

February 11, 2009
09-06

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

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PRODUCT 
Benziq Wash (Benzoyl Peroxide 5.25%), Net Wt 175 g (5.8 oz), Rx only, NDC 13453-200-18. Recall # D-182-2009
CODE
Lot number: F07E087
RECALLING FIRM/MANUFACTURER
Recalling Firm: Graceway Pharmaceuticals LLC, Bristol, TN, by e-mail on January 26, 2009.
Manufacturer: Harmony Labs, Inc., Landis, NC. Firm initiated recall is ongoing. 
REASON
Subpotent; Benzoyl Peroxide at 6 months timepoint.
VOLUME OF PRODUCT IN COMMERCE
5,855 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0444-09;
b) Platelets, Recall # B-0445-09
CODE
a) and b) Unit: 9082926
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on June 2, 3008, letter on June 25, 2008 and by e-mail on September 17, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT 
Whole Blood CPDA-1, Recall # B-0468-09
CODE
Unit: LJ45957
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by fax on February 23, 2006. Firm initiated recall is complete.
REASON
Blood product, that was not quarantined after receiving information concerning post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT 
a) Red Blood Cells, Recall # B-0472-09;
b) Platelets, Recall # B-0473-09
CODE
a) and b) Unit: 2042362
RECALLING FIRM/MANUFACTURER
Avera McKennan Hospital and University Health Center, Sioux Falls, SD, by letter on January 18, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
SD

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

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PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0470-09
CODE
Units: 303549812, 303549872
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fargo, ND, by telephone on April 16, 2006. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
ND
___________________________________
PRODUCT 
Source Plasma, Recall # B-0471-09
CODE
Unit: FZ008224
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc., of Wisconsin, Milwaukee, WI, by e-mail on March 8, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

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PRODUCT 
Medtronic O-Arm Intraoperative Imaging System, Catalog number: Bl-700-0027, Recall # Z-0624-2009
CODE
Software versions prior to version 3.0.2 S/N: 102-155
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Navigation, Inc., Louisville, CO, by site visits on November 27, 2007.
Manufacturer: Medtronic Navigation, Inc., Littleton, MA. Firm initiated recall is complete.
REASON
Navigation accuracy problem: Accuracy may fall outside of specification when used in combination with the Medtronic Synergy Experience StealthStation System Spine Software with the O-Arm Intraoperative Imaging System and tracker.
VOLUME OF PRODUCT IN COMMERCE
54 units
DISTRIBUTION
Nationwide, Canada, Czech Republic, Denmark, Germany, Netherlands, South Korea, Poland, South Africa, and Singapore
___________________________________
PRODUCT 
Excelsior SL-10 Microcatheter, placed in sterile pouch. The ExcelsiorTM SL-10 Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature; a) Model Number M0031681890, Catalog Number 168189, b) Model Number, M0031681810, Catalog Number 168181. Recall # Z-0627-2009
CODE

a) Domestic Lot/Batch Numbers: 9410580 11094006 9182538 9410580 9797825 11002715 11279121 9797825 11112088 9549061 9761925 9812892 11037582 11022392 11103887 11055248 9468202 11279121 9489075 9558487 11022392 11037582 9567011 9539686 11055248 11280366 9360513 11103722 11037582 11103887 9474771 9563837 9549061 9786599 8559155 9407572 9403111 9466592 9567133 9403111 9410580 9463008 9474934 9805069 9797825 9805069 11022392 11103722 11051431 11103889 11016347 11021069 8559155 9277244 9407574 9323623 9466592 9497150 9407574 9410580 9420194 9539686 9805069 9761923 9797825 11025202 11094006 11021070 9811899 11086559 11279696 11085511 11086559 9360513 11137647 11085284 9277244 9558487 11037582 9786599 9800091 11097465 9497151 9800091 11103886 11055248 9549849 9549062 9813014 9702841 9797824 9797726 11085282 11103886 11002715 11129185 11065054 11112088 9539686 9786599 11103887 11085282 11093861 9474771 9497151 9796878 11023381 11095396 11055248 9471043 11023381 9786599 11034065 11120294 9360513 9471043 9471044 9565700 9540909 9805069 9812499 11002716 9761925 11103722 11085282 11037582 9811899 11065054 11095396 11276374 11110298 11152045 11107242 9800091 9797825 11021072 9797825 11085284 11103886 11279696 11280366 11085511 9796878 9414130 9439020 9468202 9549062 11002715 11279696 9439020 9335697 8559155 9323623 9335694 9323623 9328893 9323623 9332195 9414130 9403111 9360513 9335694 9417932 9317444 9463008 9407572 9439020 9427379 9407574 9471043 9418154 9567011 9563838 9521760 11092289 11107242 9414130 9466590 9427378 9497151 11103722 11065056 11153871 9497151 11103889 8559155 9466592 9549060 11016347 8563856 9466592 9474771 9761925 9778433 9797824 11037582 11280366 11103889 9563837 9796878 11021069 11021072 11108176 11283875 11110298 11146441 9549062 9323623 9558487 9761925 11150467 11034065 9317444 9427379 9812497 9562124 9812497 11110298 9815767 8559155 9471044 9407574 11085511 9761923 11120293 9468202 11002715 11037582 9182538 9497151 9786599 11021070 11071036 11137647 11095396 11129185 11023381 11073526 11137647 11146238 11021069 9815767 9317444 9815768 11036567 8563856 9277244 9357310 9414130 9471044 9474934 9439931 9471044 9805069 9549061 9812497 9797824 11025202 11002430 11051431 11108176 9800091 11071037 9563838 11065054 9805069 9357310 9414130 9427379 9549060 9549061 11112088 9332195 9414130 9427379 9471043 9466591 9539686 9562126 9549849 9567133 9427379 9332195 11021072 11021069 11025202 11021069 11110298 11107242 9474934 11120294 9328893 9277244 9796878 9471043 9417932 9797825 9418154 9471047 9468202 9407574 9474771 9435037 9565700 9812497 9797824 9812891 9813014 11055248 9811899 11086780 11153871 9328893 9414130 11103722 9407572 9407574 9540909 9335697 9805069 11037582 11093861 11088219 11280366 9562124 11103889 11036567 11129185 11152045 11054197 11280366 9797824 11016347 11055248 9414130 9328893 9812361 9539334 9407572 9489075 9496078 9463008 9417932 9567133 9427379 9463008 9427379 9556944 9439020 9463008 9815767 9702841 9797824 11023381 9812891 9817640 11021072 11022392 11103886 11085284 11088219 11129185 11085511 11153871 11085284 9811899 11071037 11023381 11153871 11279121 11021072 9549849 9182538 9417932 9815768 9812891 9796878 9817640 11036567 9812499 11065054 11085511 11086780 9357310 9407574 9277244 9474935 9497150 9471044 11094006 11097465 11225675 8559155 9497151 11103722 9521763 9420194 9471043 9277244 9328893 9277244 9317444 9403111 9539686 11103889 9800091 11094006 11088219 9317444 9439020 9800091 11103886 11134246 11283875 9489075 9474935 9815768 9797824 9817640 11103887 11103722 11021070 11093860 9815767 9407574 11120293 9417931 9468202 9420194 9521763 9471044 9815767 9812891 11016346 11051431 9815768 9812361 9182538 9439020 9526083 9563837 11085282 9474771 9466591 9797824 9812892 9815768 11021069 11103887 9797825 11021069 11103722 9797824 11036567 11103886 11276374 11086559 11120293 9562126 9489075 9796877 9797824 11022392 11051431 11107242 9549062 9812497 11150468 11021072 11025202 11103722 11279121 9549062 11023381 11002430 9474771 9471043 9567133 9563837 9815767 9562124 9471043 11034065 11073526 9800091 11016346 9811899 9439020 9468202 9817640 11016346 11279121 11120293 9786599 11023381 11021072 11002430 9317444 9182538 9317444 9407572 9474771 9335697 9563837 9815767 11279121 11103887 9466592 9539334 11121598 9549062 9521763 9317444 9562124 9182538 9562126 9466592 11085284 9435037 9335697 8559155 9407574 9414130 9439020 9407572 9471043 9414130 9549060 9797825 11021069 11279121 11055248 11092289 11150468 9563837 9420194 9796878 11103887 9539686 9796878 9817388 9812891 11085284 11085282 11016347 11085511 9474934 9427379 11088219 9332195 9761923 9489075 9702841 9496078 11103722 11150468 9403111 9328893 9567011 9796878 9489075 11103886 9332195 9435037 9317444 9360513 9474771 9815768 8563856 9563838 9549062 11034065 11025202 11073526 9797824 11016347 11103887 11107242 9463008 9317444 9497151 9549061 9471044 9702841 11002715 11103886 11021069 11093861 11103886 8563856 9812497 9815767 11085282 11073526 9466590 9817640 11021069 9812361 11021070 8563856 9332195 9328893 9407574 9439020 9497150 9466591 9407574 9474771 9463008 9439929 9439020 9489075 9439929 9558487 9549061 9567133 9526083 9539688 9563837 9558486 9563837 9549060 9335697 9565700 11036567 9812891 9786599 9812891 11021069 11103889 11016346 11022392 9796878 11022392 11037582 11034065 11182789 11021069 11085282 11016346 11086559 11280366 11110298 11055248 11150468 11121598 11093860 11092289 11112088 11073526 11022392 9815768 11150467 9439020 9549061 9549062 9489075 9797824 11025202 11225675 9526083 9800091 9778171 11037582 9813014 11103722 9796878 11150468 11107242 9521760 9815767 11129185 11088219 9796878 9812497 9761925 11002430 8563856 9539334 9549062 9779107 11065056 11086559 9497150 9751645 9735635 9817640 11021070 11225676 9797825 11055248 9439020 9567133 9563837 9817640 11103887 11150468 11134246 9812361 11153871 11121598 9407572 9567133 9463008 9357310 9420194 9549062 9556943 9556944 9812891 11021069 11085511 11065054 11153871 11065054 11112088 9182538 9332195 9439020 9563837 9420194 9796878 9549060 9817640 9812891 11002430 9497152 11016346 9797824 11085511 11021069 11023381 8559155 9539686 9562126 9796877 9817640 11097465 11023381 9779107 11095396 11120293 11121598 11103887 9414130 11085284 11088219 9815767 9797726 11016346 8563856 9439020 9435037 9521763 9439020 9497150 9439020 9471043 9562126 9466590 9471044 9797824 9754894 9812892 9805069 11103889 9800091 11002716 11129938 9797825 9812497 11153871 11021072 11279696 9761923 11279121 9332195 9328893 9439932 9468202 9540909 9420194 9435037 9565700 9563837 9797726 11021069 11037582 11103722 11097465 9562126 9812892 11055248 11129185 11121598 9471043 9323623 9489075 9549062 9562126 9562124 11002716 11108176 11023381 11022392 8563856 8559155 9332195 9357310 9407574 9407572 9407574 9407572 9407574 9357310 9489075 9439020 9466592 9471044 9471043 9497150 9526083 9420194 9471044 9497151 9565700 9521760 9567133 9526083 9558487 9539686 9805069 9796878 9797824 9815768 9812891 9815767 9558487 9761925 9815767 11002715 9761925 9815768 9735635 9797824 11002430 9803722 11093861 9817388 11085282 11103722 11103889 9797824 11108176 11016347 11055248 11103722 9811899 11086780 11279121 11110298 11120293 11071036 11146238 11121598 11110298 11021072 9466590 11103887 8563856 9521763 9558487 11086780 9435037 9471044 9567133 9786599 11085282 9797824 11065054 8563856 9323623 9317444 9277244 9407574 9323623 9410580 9357310 9463008 9328893 9435037 9466590 9463008 9471047 9474771 9474934 9418154 9549061 9539686 9761923 9812497 9817640 9761925 9797825 9761925 9817640 11036567 9797726 9817640 11093861 11021069 9786599 11021070 11103887 11093861 11103886 9812497 11022392 11055248 11279121 9811899 11065056 11279121 11095396 11225675 11055248 11110298 11279121 11093860 11148046 11073526 11112088 9332195 9360513 9407572 9567011 11036567 11108176 11085282 11093861 11097465 11280366 9539686 11107242 11071037 9466591 9468202 9414130 9471044 11103887 9761925 11023381 9418154 11146441 11086559 8559155 9417932 9497151 9466592 9471043 9357310 9562124 9549061 9815768 11002716 9796878 11103887 11016347 11276374 11103886 11085284 11055248 11085282 9332195 9562126 9797824 11021072 9335697 9565700 9521760 11051431 11112088 11093861 9549061 9332195 9410580 11071037 11036567 9466592 8559155 9419872 9549062 8559155 9540908 9565700 9761925 9702841 9805069 11182789 9471047 9471044 9567011 11022392 11025202 11071036 11002430 11021069 9414130 9410580 9463008 9471043 9558487 9466592 9812891 9815767 11025202 9761923 9761925 9567133 9489075 9539686 11120294 9435037 9539686 11051431 9471047 9407574 9815768 8563856 9182538 9323623 9414130 9357310 9414130 9417932 9407574 9471043 9489075 9549062 9526083 9549062 9563837 9463008 9562124 9549849 9805069 11103887 11088219 9812361 11279696 11085511 11279121 11055248 11071037 11112088 11071037 9812892 8559155 9323623 9414130 9410580 9468202 9410580 9497151 9407574 9435037 11025202 11103889 11065054 11283714 9407574 9468202 9549060 9761923 9796878 11037582 11036567 11055248 11085511 11086559 11153871 9567133 9497151 9565700 9761923 9812891 9800091 9796878 11112088 9471043 11036567 9489075 11280366 9435037 9471043 9407574 9417932 11103886 9332195 9407574 9489075 9471043 9539686 9549060 9497150 9565700 9317444 9565700 9761923 9761925 11016346 9761925 11002715 11021072 11093860 11120294 11121598 9466591 9328893 9463008 9549061 9497150 9562126 9549061 9328893 9796878 11085282 11276374 9797824 11071036 9468202 9439020 9549062 11279696 11153871 11071037 11088219 11121598 9417932 11021070 9811899 9497151 9539686 9182538 9567011 11279121 9811899 8559155 9407572 9702841 11225675 9474771 9797825 9360513 9407574 11002430 9360513 9435037 9471044 9489075 11144685 11085284 9805069 9360513 9417931 11088219 9439931 9563838 9417932 9419872 9549062 11280366 11103884 9812891 11095396 11112088 9323623 11016347 11279121 11092289 9407572 9562126 11085282 11280366 11276374 9332195 9418154 9407572 9539334 9797824 11283875 9549060 11025202 9357310 9471044 9813014 9496078 11088219 9410580 9474934 9521763 9800091 9549849 9563838 9817640 11022392 11225675 11279121 11153871 9418154 9417932 11225675 11225676 9435037 9558486 9761925 9471043 9567133 9466591 9407572 9539686 9463001 11103886 9563837 9496078 9797825 11055248 9328893 9360513 9549060 9474934 9796878 9549060 9786599 9797825 11002430 11023381 11112088 11107242 9812497 9805069 9420194 9786599 11094006 11095396 9497151 11092289 11034065 11120293 9417932 9463001 11088219 9489075 9539686 9474771 9549060 9813014 9549060 11103889 11021072 11054197 9761925 9786599 11055248 11225676 11085511 11110298 11085284 11095396 9497150 9332195 11021070 9562124 9566693 11097465 11103886 11021069 9328893 9407572 9539334 11036567 11025202 11022392 11103886 11182789 11276374 11036567 11146441 8563856 9435037 9417932 9466590 9497151 9471043 9565700 9556944 9420194 11283714 11279696 11283714 11146441 11065054 11148046 9562124 9702841 11182789 11103886 9435037 9800091 11088219 9812497 9497150 11103889 11112088 9317444 9471043 9466590 9526083 9497151 11022392 9335697 9556943 9563838 9539334 9549061 9761925 11088219 11023381 11022392 11150468 9761925 11055248 11095396 11103884 11152045 11112088 11085284 9817640 9317444 9328893 9466590 8563856 8559155 9463008 9410580 9471044 9549849 9466591 9567011 9539334 9407572 9549849 9335697 9549849 9761923 9812497 9563838 11036567 11108176 11103889 11085282 11085284 11132217 11085282 11095396 11146441 11110298 11150467 11110298 11137647 11086559 11152045 9812891 9357310 9418153 9435037 9566519 9805069 11025202 11036567 11085284 8563856 9420194 9567133 9563837 9813014 9549849 9796878 11085282 11283714 9813014 9761925 8563856 9277244 9357310 9439020 9418154 9471044 9556944 9539334 9549060 9562124 9556944 9786599 11002430 9755342 9761924 9813014 11034065 9800091 11016346 11108176 9761923 9800091 11021069 11085282 11103887 9563837 11134246 11146441 11153871 11110298 11085511 11146441 11103884 11153871 11225675 11120293 11279121 11073526 11107242 9563837 11002430 9811899 9805069 9466590 11002715 9466590 9182538 9474771 9539334 9796878 9521764 11016346 11002715 11065056 11153871 11150467 11112088 9435037 9417932 9812891 9812497 11103722 11054197 11280366 11055248 11146238 9563837 11034065 9812361 11055248 9563837 9526083 11108176 11025202 11002715 11023381 11276374 11135840 11279121 9417932 11073526 9796878 9539688 11002715 9471043 9466590 9540909 9277244 9549061 9813014 11283875 9521760 9471047 9549062 9812892 9332195 9414130 9323623 9761923 9761925 9702841 9796877 11110298 11279696 11146238 11093860 9414130 9419872 9526083 9539334 9558486 9526083 9815768 9815767 9497151 9805069 9797825 11085284 11279696 11280366 11093861 11021072 11016346 11279696 9277244 11022392 9539334 9786599 9521760 11279696 9468202 9563837 11021069 11093860 9526083 9277244 11279121 8559155 11021069 11037582 9463008 9496078 9521760 9817388 9539334 9563837 9797825 9357310 9420194 8559155 9474771 9471043 9539334 11093861 9417932 9427379 9549061 9549060 9474771 9539688 9797825 11021072 11086559 11129185 9427379 9702841 11120294 9567133 9539688 9563837 9805069 11086559 11137647 9466590 9471043 11103889 9420194 9812892 11016346 11153871 11280366 9471043 9474934 9427379 9812497 9778171 11103889 11108176 11103889 11085282 11025202 11065054 11065056 9357310 9496078 9466591 9420194 9558487 9471043 11103722 11279121 11146238 11280366 11037582 11071036 11071037 9815768 11134246 9466591 11021072 11085284 9466592 9497150 8563856 9439929 9466592 9521763 9549849 9427379 9489075 9558487 9800091 11051431 9427379 11103886 11071037 11283875 11110298 11002430 9410580 9496078 9489075 9474771 9539334 9420194 9539334 9466590 9805069 9812499 11108176 11225675 11112088 9332195 9439020 9549060 9471044 11022392 11036567 11022392 11002715 9570584 11280366 9418154 11121598 9435037 11086559 11022392 11055248 11150467 11002430 11093861 9403111 9360513 9466592 9419872 9439929 9549060 9466590 9420194 9521760 9817640 11025202 11034065 11021069 11085282 11021069 11085282 11021069 11016346 11002715 11002716 11065054 11134246 11065056 11279696 11065056 11280366 11086559 11283875 11085511 9335694 9323623 9558486 9562126 9812892 11095396 11283875 11112088 11073526 9539686 9565700 9418154 9539334 9471044 9435037 11002430 9427377 11002715 9812497 9813014 9817640 11025202 9797824 11034065 11103889 11025202 11021070 11103889 11036567 11103722 11036567 11108176 11021070 11108176 11054197 11146441 11095396 11065056 11023380 11112088 11092289 9786599 11112088 9317444 11021072 11023381 8563856 9328893 9410580 9328893 9521763 9549060 9539334 9474935 9558486 9812497 9786599 11002430 11094006 9796878 11110298 9811899 9463001 11129185 11120294 11107242 11112088 9489075 11279696 11110298 11085511 11152045 8563856 9427379 9420194 9797726 11051431 11103889 9332195 9497151 9474771 9549060 9566693 11134246 9812497 9407572 9436977 9539334 9549062 9439931 11276374 11153871 9761923 9812497 11002430 8559155 9786599 9815768 9797824 9417932 9800091 11103886 9812892 9800091 9410580 9562126 9565700 11023381 11283714 11132217 11134246 9800091 9323623 8559155 9474934 9702841 9817640 11280366 9761923 9497151 9539334 9474935 9812497 9182538 9805069 9796878 9797825 11086780 11280366 11095396 11146238 11093860 11065054 9562124 9812891 11002430 11103886 9812497 11146238 9328893 11279121 9549849 11103889 11065054 11036567 9797824 11108176 9468202 9489075 9812891 9813014 11110298 9407572 9562124 9549060 11103722 11103889 11088219 9563837 9328893 9360513 9328893 9558487 11036567 9319889 9407574 11225675 11093860 9815767 11085282 9761924 9474771 9410580 9471044 9570584 9805069 11051431 11095396 9328893 11002430 9414130 9549062 9335697 9357310 11051431 9562124 9796878 9815768 11086559 8559155 9562124 9815768 9761923 11036567 11103722 11034065 11002716 9761925 11097465 9474771 9562124 9786599 9812892 11016346 11280366 9360513 9317444 9319889 9407572 9417932 9539334 9521760 9417932 9565700 9562126 9489075 9566693 9812891 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b) Lot/Batch Numbers: 9703869 9582725 11032901 9563839 9703869 11017848 11018893 9582725 11017847 11018893 11067023 11032901 9800280 9750583 9446914 9637671 11257964 9703869 11017847 9499078 9750583 11067023 9750583 9827896 9499078 11018895 11017848 9499078 11019057 9827896 9582725 11007160 9446914 9703869 9750582 9582725 11018893 9827896 9446914 11019057 9499078 11017847 9499078 9800280 9446914 9499078 9582725 9446914 9582725 9827896 11017848 9827896 11017847 9637671 11018895 9827896 11017847 9563839 11007160 9800280 9563839 11018893 11067023 11032901 11017847 11019057 11032901 9703869 9499078 9637671 9582725 9750583 9582725 9637671 9446914 11019057 9827896 9563839 11018893 11032901 9750582 9827896 9499078 11018893 9563839 11019057 11067023 9750583 9703869 11032902 9582725 9827896 11019057 11018895 9582725 9563839 9750583 9800280 11018893 11067023 11017848 11018893 9446914 9563839 9582725 11032902 11007160 11257964 11067023 11018893 9499078 9800280 9750582 9800280 9750582 11018895 11019057 9446914 9750582 9582725 11017847 9703869 9637671 11017848 11018893 11032901 9800280 9499078 9637671 11018895 11067023 11018893 11032902 11067023 9499078 11017848 11017847 11067023 11019057 9750582 9637671 9827896 11017847 9827896 9750582 11032902 11018895 11257964 9563839 11017847 11067023 9750582 11067023 9563839 11017848 11018893 9499078 11018894 9563839 9499078 9750583 9827896 11067023 9827896 9637671 9703869 9827896 9703869 11017848 9446914 11019057 9499078 9446914 9582725 11017848 11032902 9827896 9800280 11019057 9800280 9499078 9750582 9446914 11017847 11018893 11067023 9750582 9499078 11017847 9800280 11018893 9750582 9446914 11018895 9750582 11032901 11017847 9827896 9563839 11018893 9750582 11007160 9750583 9582725 9563839 9827896 11018893 11067023 9827896 11018895 11032901 11032902 11019057 9499078 9446914 9750583 9750582 9637671 9446914 9800280 9446914 11017848 11257964 9800280 9637671 9499078 9750582 9499078 9563839 11019057 9750582 9827896 9800280 9563839 11017848 11017847 9637671 9499078 9582725 9637671 9750583 9637671 9800280 9750582 9446914 9499078 9582725 11032901 9800280 11067023 11018893 11017847 11019057 9563839 11018894 9750582 9750583 9563839 9446914 9800280 11017848 9827896 11018893 9750582 9800280 9827896 11257964 9637671 9827896 11257964 11018895 11017847 11018893 9703869 11017848 11017847 11067023 9827896 11018895 9637671 9582725 0009213455 0009224253 0009224267 0009368091 0009368638 0009368640 0009446914 0009499078 0009563839 0009582725 0009613990 0009637671 0009645145 0009668007 0009678226 0009678228 0009703869 0009750582 0009750583 0009800280 0009827896 0011007160 0011007161 0011017847 0011017848 0011018893 0011018894 0011018895 0011019057 0011032901 0011032902 0011067023 0011257964 and 0011261956.
For International Lot Numbers, contact your Boston Scientific Corporation representative.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corporation, Fremont, CA, by letter dated October 7, 2008. Firm initiated recall is ongoing.
REASON
Packaging issue may result in failure to maintain sterile barrier.
VOLUME OF PRODUCT IN COMMERCE
21,423 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
a) Stryker Medical Stair-PRO Stair-Chair with wheels, patient transport device, Model 6251. Recall # Z-0648-2009;

b) Stryker Medical Stair-PRO Stair-Chair with wheels and a track system, patient transport device, Model 6252. Recall # Z-0649-2009;

c) Stryker Medical Stair-PRO Evacuation Chair civilian use stair chair, patient transport device, Model 6253. Recall # Z-0650-2009
CODE
a) Serial numbers: 080940844, 080940845, 080940858, 080940819, 080940820 and 080940640;

b) Serial numbers: 080940553, 080940768, 080940600, 080940601, 080940831, 080940592, 080940899, 080940821, 080940822, 080940766, 080940767, 080940597, 080940642, 080940643, 080940832, 080940833, 080940834, 080940835, 080940836, 080940580, 080940581, 080940825, 080940639, 080940595, 080940596, 080940589, 080940765, 080940838, 080940839, 080940840, 080940607, 080940608, 080940829, 080940594, 080940582, 080940583, 080940584, 080940611, 080940612, 080940613, 080940830, 080940763, 080940826, 080940827, 080940871, 080940644, 080940859, 080940860, 080940861, 080940862, 080940863, 080940864, 080940865, 080940866, 080940867, 080940868, 080940869, 080940828, 080940593, 080940760, 080940761, 080940898, 080940837, 080940551, 080940552, 080940752, 080940769, 080940873, 080940874, 080940875, 080940876, 080940877, 080940641, 080940770, 080940843, 080940247, 080940248, 080940762, 080940842, 080940753, 080940754, 080940755, 080940756, 080940757, 080940758, 080940759, 080940841, 080940587, 080940588, 080940585, 080940586, 080940771, 080940550, 080940645, 080940646, 080940647, 080940648, 080940649, 080940750, 080940751, 080940823, 080940824, 080940870, 080940764 and 080940872;

c) Serial numbers: 080940895, 080940896, 080940578, 080940614, 080940615, 080940616, 080940618, 080940619, 080940620, 080940621, 080940623, 080940624, 080940625, 080940626, 080940628, 080940880, 080940571, 080940572, 080940573, 080940574, 080940575, 080940576, 080940629, 080940630, 080940599, 080940554, 080940555, 080940887, 080940888, 080940889, 080940890, 080940891, 080940892, 080940893, 080940894, 800940881, 080940772, 080940773, 080940774, 080940564, 080940565, 080940566, 080940850, 080940856, 080940556, 800940557, 080940558, 080940559, 080940560, 080940561, 800940562, 080940563, 080940633, 080940634, 080940635, 080940636, 080940245, 080940246, 080940851, 080940852, 080940853, 080940854, 080940846, 080940847, 080940848, 080940849, 080940810, 080940811, 080940812, 080940813, 080940814, 080940815, 080940577, 080940631, 080940632, 080940617, 080940622, 080940627, 080940818, 080940857, 080940882, 080940897, 080940816, 080940817, 080940567, 080940568, 080940569, 080940570, 080940579, 080940800, 080940801, 080940802, 080940878, 080940879, 080940855, 080940883, 080940884, 080940885, 080940886, 080940637, 080940638 and 080940803
RECALLING FIRM/MANUFACTURER
Stryker Medical Division of Stryker Corp., Portage, MI, by letter dated November 18, 2008. Firm initiated recall is ongoing.
REASON
Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation.
VOLUME OF PRODUCT IN COMMERCE
213 chairs
DISTRIBUTION
Nationwide, India, Netherlands and United Kingdom
___________________________________
PRODUCT 
a) Terumo Advanced Perfusion System 1 Air Bubble Detection Module; Catalog number 802110. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures. Recall # Z-0670-2009;

b) Terumo Advanced Perfusion System 1 Pressure Monitoring Unit; Catalog number 802112. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures. Recall # Z-0671-2009;

c) Terumo Advanced Perfusion System 1 Temperature Monitoring Systems; Catalog number 802114. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures. Recall # Z-0672-2009;

d) Terumo Advanced Perfusion System 1 Pressure Venous Occluder; Catalog number 803480. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures. Recall # Z-0673-2009;

e) Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures. Recall # Z-0674-2009
CODE
a) Serial number: 0727;

b) Serial numbers: 00001 through 01246, 01257 through 01277, 01279 through 01286, 01288 through 01295. 01298 through 01308, 01310 through 01315 and 01319 through 01320;

c) Serial number: 0637;

d) Serial number: 0220;

e) Serial number: 0188 
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter on November 16, 2007 and by e-mail on November 21, 2007. Firm initiated recall is ongoing.
REASON
The system may malfunction due to t-filter corrosion on an internal circuit board.
VOLUME OF PRODUCT IN COMMERCE
1,219 units
DISTRIBUTION
Nationwide and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam
___________________________________
PRODUCT 
Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456. Medical device, intended for ultrasound examination of peripheral pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. Recall # Z-0837-2009
CODE
Batch/Lot numbers: 11420600, 11420601, 11420602, 11611665, 11716746, 11720663, 11721240, 11722752, 11727107, 11727873, 11727874, 11728458, 11731354, 11732665, 11735762, 11736559, 11739563, 11742590, 11754455, 11758051, 11764281, 11777994, 11788045, 11790848, 11820112, 11897802, 11897904, and 11904295
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Fremont, CA, by letters on October 8, 2008. Firm initiated recall is ongoing.
REASON
Product is mislabeled as having a shelf life of 3 years, where the actual shelf life is 1 year.
VOLUME OF PRODUCT IN COMMERCE
1,033 units
DISTRIBUTION
Nationwide and Panama
___________________________________
PRODUCT 
a) REF: 915-1006 Lactosorb System, Lacto Endobrow Lift Complete, 10X13CM. (3.75X5.25") (WXL), Polypropylene, Radel. Non Sterile Product. Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. Recall # Z-0864-2009;

b) REF: 915-1000 Lactosorb, Office Fixation Kit, 1 Screwdriver, 1 Tap Handle, 1 Drill Bit, 1 Screw Extractor, 1 Self Drilling Tap, S/S. Aluminum , Teflon, Ra del. Non Sterile Product. Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. Recall # Z-0865-2009;

c) REF: 01-6871 IMF Set 254 X 127 X34MM (10"X1"X1.2") Polypropylene, Radel, AL, SS, T.C. Non Sterile Product. Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. Recall # Z-0866-2009;

d) REF 01-6851 Office System 1.5/IMF Small Office Set, 156MMX125MM, (6.4"X4.9") Polypropylene, Ultem, Radel, AL, SS. Non Sterile Product.  Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. Recall # Z-0867-2009
CODE
a) Lot numbers: 026660, 044820, 044830, 044900, 069630, 119940, 175710, 207320, 286830, 323270, 373220, 375190, 393190, 396390, 464030, 620270, and 718350;

b) Lot numbers: 056960, 060930, 071130, 085650, 155540, 181390, 2247100, 248520, 368120, 584110, 716090, 716100, 716110, 717510, 782200, 851620, 990550, and 999999;

c) Lot numbers: 907650, 252341, and 300870;

d) Lot numbers: 108450, and 103010
RECALLING FIRM/MANUFACTURER
Biomet Microfixation, Inc., Jacksonville, FL, by letters on August 26, 2008, August 27, 2008, September 26, 2008, October 28, 2008 and November 13, 2008. Firm initiated recall is ongoing.
REASON
The finished trays were packaged and shipped to facilities without the instructions for use and without the single use symbol on the packaged tray label.
VOLUME OF PRODUCT IN COMMERCE
420 units
DISTRIBUTION
Nationwide and countries of Argentina, Australia, Canada, Columbia, Hong Kong, Japan, Mexico, New Zealand, Puerto Rico, Taiwan, Thailand, Denmark, France, Netherlands, Greece, Italy, Norway, Finland, Spain, Czech Republic, and Venezuela
___________________________________
PRODUCT 
Restoration Modular Conical Distal Stem; Sterile, Titanium Alloy. One unit per package. This system is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. Catalog No. 6276-7-017 (17mm), Catalog No. 6276-7-014, (14mm). Recall # Z-0884-2009
CODE
Lot Code CAXHA68D; Lot Code CAXHB18A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on November 21, 2008.
Manufacturer: Stryker Ireland, Ltd., Orthopedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is ongoing.
REASON
Stryker became aware of a lot for lot mix up.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at the FCC authorized medical device frequency of 27.12 MHz. Provant transmits a fixed dose of non-ionizing, non-thermal RF energy via an applicator pad that is placed adjacent to the patient's dressed wound. The Provant Wound Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. Recall # Z-0887-2009
CODE
Serial Numbers: 704, 920, 460, 709, 711, 714, and 727
RECALLING FIRM/MANUFACTURER
Regenesis Biomedical Inc., Scottsdale, AZ, by letter dated September 29, 2008. Firm initiated recall is complete.
REASON
Under certain unusual clinical circumstance, the affected devices may be unable to generate a therapeutic dose of radio frequency energy. As such, for these few devices, the effectiveness of Provant therapy may be impaired.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
WV, VA and NC
___________________________________
PRODUCT 
a)  Solar Shoulder Humeral Stem. These devices are modular components of a total shoulder system. These humeral stems are intended for use with humeral heads and glenoid components in primary or revision total shoulder arthroplasty. Catalog Numbers, Description 5351-4103 SHOULDER - HUMERAL STEM 7mm, 5351-4105 SHOULDER - HUMERAL STEM 9mm, 5351-4105 SHOULDER - HUMERAL STEM 9mm, 5351-4107 SHOULDER - HUMERAL STEM 11mm, 5351-4108 SHOULDER - HUMERAL STEM 12mm, 5351-4108 SHOULDER - HUMERAL STEM 12mm, 5351-4109 SHOULDER - HUMERAL STEM 13mm VWHMKE, 5351-4110 SHOULDER - HUMERAL STEM 14mm HTXMKE, 5351-4110 SHOULDER - HUMERAL STEM 14mm, 5351-4113 SHOULDER - HUMERAL STEM 17mm, and 5351-4205 SHOULDER - HUMERAL 200mmX9mm. Recall # Z-0888-2009;

b) Triathlon Cemented Stem - Knee These devices are modular components of a total knee system. These modular stems are intended for use with femoral and tibial components in primary or revision total knee arthroplasty. Item Number, Product Name: 5560-S-209 TRI CEMENTED STEM 9MMX100MM and 5560-S-209 TRI CEMENTED STEM 9MMX100MM. Recall # Z-0889-2009;  

c) Triathlon-Press-Fit Stem These devices are modular components of a total knee system. These modular stems are intended for use with femoral and tibial components in primary or revision total knee arthroplasty. Catalog numbers, Description: 5565-S-015 TRI PRESS-FIT STEM 15MM X 100MM, 5565-S-016 TRI PRESS-FIT STEM 16MM X 100MM, 5565-S-016 TRI PRESS-FIT STEM 16MM X 100MM, 5565-S-017 TRI PRESS-FIT STEM 17MM X 100MM, 5566-S-012 TRI PRESS-FIT STEM 12X150MM, 5566-S-013 TRI PRESS-FIT STEM 13X150MM, and 5566-S-018 TRI PRESS-FIT STEM 18X150MM. Recall # Z-0890-2009;
 
d) Omnifit HA Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog number, Description: 6017-0525A OMNIFIT HA HIP STEM #5 and 6017-1035A OMNIFIT HA HIP STEM #10. Recall # Z-0891-2009;

e) Omnifit Normalized Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog number, Description: 6034-0730 OMNIFIT NORMALIZED HIP STEM. Recall # Z-0892-2009;

f) Secur-Fit Max Hip Stem. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog numbers, Description: 6051-0625S SECUR-FIT MAX 132 HIP STEM #6, 6051-0730S SECUR-FIT MAX 132 HIP STEM #7, 6051-0730S SECUR-FIT MAX 132 HIP STEM #7, 6051-0830S SECUR-FIT MAX 132 HIP STEM #8, 6051-0830S SECUR-FIT MAX 132 HIP STEM #8, 6051-0935S SECUR-FIT MAX 132 HIP STEM #9, 6051-1035S SECUR-FIT MAX 132 HIP STEM #10, 6051-1140S SECUR-FIT MAX 132 HIP STEM #11, 6051-1140S SECUR-FIT MAX 132 HIP STEM #11, 6052-0830S SECUR-FIT MAX 127 HIP STEM #8, 6052-0935S SECUR-FIT MAX 127 HIP STEM #9, 6052-1035S SECUR-FIT MAX 127 HIP STEM #10, 6052-1035S SECUR-FIT MAX 127 HIP STEM #10 and 6052-1240S SECUR-FIT MAX 127 HIP STEM #12. Recall # Z-0893-2009;

g) Primary Secur-fit Plus Max Hip Stem. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog numbers, Description: 6054-0812S PRIMARY SECUR-FIT PLUS MAX #8/12, 6054-0812S PRIMARY SECUR-FIT PLUS MAX #8/12, 6054-0915S PRIMARY SECUR-FIT PLUS MAX #9/15, 6054-1014S PRIMARY SECUR-FIT PLUS MAX #10/14, 6054-1014S PRIMARY SECUR-FIT PLUS MAX #10/14, 6054-1014S PRIMARY SECUR-FIT PLUS MAX #10/14 and 6054-1218S PRIMARY SECUR-FIT PLUS MAX #12/18. Recall # Z-0894-2009;   

h) Accolade C CS. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog number, Description: 6057-0335D ACCOLADE C CS 127 NK, 6057-0537D ACCOLADE C CS 127 NK, 6057-0740D ACCOLADE C CS 127 NK and 6058-0335D ACCOLADE C CS 132 NK. Recall # Z-0895-2009;

i) Omnifit HFX Hip Stem. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog numbers, Description: 6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132, 6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132, 6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 and 6070-1140A OMNIFIT HFX HIP STEM SIZE #11 132. Recall # Z-0896-2009;

j) Accolade HFx. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.  Catalog # Description: 6077-0230 Accolade HFx Size #2, 6077-0230 Accolade HFx Size #2, 6077-0335 Accolade HFx Size #3, 6077-0435 Accolade HFx Size #4, 6077-0435 Accolade HFx Size #4 and 6077-0435 Accolade HFx Size #4. Recall # Z-0897-2009;

k) Omnifit FC Cemented Stem. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog number, Description: 6093-1035 OMNIFIT-FC CEMENTED STEM and 6093-1035 ONMIFIT FC CEMENTED STEM. Recall # Z-0898-2009;

l) Omnifit Eon. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog number, Description: 6098-0630 OMNIFIT EON 132, 6098-0630 OMNIFIT EON 132, 6098-0735 OMNIFIT EON 132, 6098-0940 OMNIFIT EON 132 and 6098-1140 OMNIFIT EON 132. Recall # Z-0899-2009;

m)  Japanese Omnifit Eon 127 NK. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Item number: J6097-0425, Item number J6097-05390. Recall number: Z-0900-2009;

n) Reunion HA Fracture Stem. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog numbers, Description: R5351-4507 REUNION HA FRACTURE STEM 7MM, R5351-4508 ReUnion HA Fracture Stem 8MM, R5351-4508 ReUnion HA Fracture Stem 8MM and R5351-4509 REUNION HA FRACTURE STEM 9MM. Recall # Z-0901-2009;

o) Secur-Fit ARC/HA Collar Stem. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog number, Description: S-2337-HF09 SECUR-FIT ARC/HA COLLAR STEM #9, S-2337-HF09 SECUR-FIT ARC/HA COLLAR STEM#9 and S-2337-HF10 SECURFIT ARC/HA COLLAR STEM#10.  Recall # Z-0902-2009
CODE
a) Lot Numbers: XKRMHE, 8ETMJE, 8EYMJE, V45MKE, VV3MKE, VV4MKE, VWHMKE, HTKMKE, T7TMKE, KKHMKE and MT9MKE;

b) Lot numbers: N3N31K, N3N31W;

c) Lot numbers: M3M07B, M3M01B, M3M01E, M3M03A, M3L11F, M3L12B, M3L17D;

d) Lot numbers: 3PMMNE, NKAMME;

e) Lot number: PJ9MLE;

f) Lot numbers: HKNMME, K03MME, K08MME, E56MLE, J41MLE, EN1MME, 70PMME, 4PMMME, 901MME, V3PMLE, 5ERMME, 69WMME, AL8MME, EP4MME;

g) Lot numbers: 72MMME, WA5MLE, 11AMME, AKKMME, AKXMME, DHKMME, EP2MME;

h) Lot numbers: JYLMME, JYNMME, E5EMME, JYVMME;

i) Lot numbers: P7MMME, RHWMME, VJMMME, 0J0MNE, D9VMME, VK0MME, T9RMME, 0HDMNE, 0HEMNE, P7XMME, RE8MME, REDMME, VK2MME, VK3MME, 0HKMNE;

j) Lot numbers: 8XAMLE, 8XEMLE, 8PAMME, 8PEMME, PJLMLE, R27MLE;

k) Lot numbers: 28RMLE, 3DHME;

l) Lot numbers: 48HMME, TAMMME, 0W9MNE, TN3MLE, 2HNMME;

m) Lot number: TN7MLE and lot number: 41WMME;

n) Lot numbers: T2T72836-J, T2N71522-I, T2T72422-C, T2N71523-G;

o) Lot numbers: 8T3MME, 99EMME, 2H0MME
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on November 21, 2008. Firm initiated recall is ongoing.
REASON
Stryker Orthopedics became aware of a visual defect in certain blister packages of certain devices.
VOLUME OF PRODUCT IN COMMERCE
322 units
DISTRIBUTION
Nationwide and countries of Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden

END OF ENFORCEMENT REPORT FOR FEBRUARY 11, 2009

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