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U.S. Department of Health and Human Services

Safety

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Enforcement Report for December 30, 2009

December 30, 2009
09-52

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
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PRODUCT 
Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434. Recall # Z-0002-2009
CODE
Serial # 00001002491WK7 00000100291WK7 00000999999WK6 00001001816WK6 00001001824WK0 00000995364WK7 00000996497WK4 00000068396WG1 00000995361WK3 00000996218WK4 00000001239M33 00001000600WK5 00000996216WK8 00000001247M36 00000998382WK6 00001001814WK1 00000995360WK5 00001004793WK4 00000998805WK6 00000994499WK2 00001006377WK4 00000997607WK7 00000999065WK6 00001004294WK3 00001005696WK8 00000998799WK1 00000997599WK6 00000992542WK1 00000069597WG3 00001004299WK2 00001002488WK3 00001002487WK5 00000998941WK9 00000998939WK3 00000995356WK3 00000993793WK9 00001000954WK6 00001001827WK3 00000998388WK3 00001005678WK6 00001003046WK8 00001001837WK2 00000035324HL3 00000997608WK5 00001002486WK7 00000998945WK0 00000995366WK2 00000998391WK7 00000994494WK3 00000993374WK8 00000037897HL6 00000001238M35 00000999698WK4 00001003557WK4 00000998383WK4 00001002483WK4 00000999993WK9 00001000956WK1 00000998386WK7 00000997605WK1 00000997602WK8 00000998938WK5 00001001810WK9 00000996491WK7 00001001085WK8 00000035064HL5 00001002490WK9 00001000950WK4 00000996495WK8 00000996791WK0 00000996500WK5 00000996209WK3 00000994488WK5 00000034881HL3 00001000951WK2 00001001799WK4 00001003566WK5 00001003045WK0 0000USU4400NXJ 00000997069WK0 00001002489WK1 00000996498WK2 00001001811WK7 00001000958WK7 00000998392WK5 00000996792WK8 00001004296WK8 00000998944WK3 00001001800WK0 00001003561WK6 00000995353WK0 00001001818WK2 00001005004WK5 00000998937WK7 00000996499WK0 00001002482WK6 00000996212WK7 00001003553WK3 00001000000WK8 00000995349WK8 00000996684WK7 00000998156WK4 00001004304WK0 00000036505HL6 00000994505WK6 00001000952WK0 00000997182WK1 00000998804WK9 00000995368WK8 00000995357WK1 00000994491WK9 00001001807WK5 00000999998WK8 00001005694WK3 00000993794WK7 00001000955WK3 00000064580WG4 00001001822WK4 00001003554WK1 00000998942WK7 00000996789WK4 00001004791WK8 00000996227WK5 00000001173M34 00001000957WK9 00000081110MA9 00001004139WK0 00001004298WK4, and 0000000069365W
RECALLING FIRM/MANUFACTURER
GE Medical Systems, LLC, Waukesha, WI, by letter dated March 7, 2008. Firm initiated recall is ongoing.
REASON
GE Healthcare has recently become aware of a potential risk of observing a blank image after exposure on Revolution XR/d systems equipped with HP 8200 PC user consoles that may impact patient safety. It was reported that images acquired with off-center collimation for extremities with the position selected as Digits to front or Digits to back are displayed as blank. Investigation into this issue revealed an error in the Revolution XR/d image processing software that controls rotation of collimator coordinates. This error causes the system to display a blank image when Digits to front or Digits to back are selected for off-center collimation exams.
VOLUME OF PRODUCT IN COMMERCE
129 units
DISTRIBUTION
Nationwide
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PRODUCT 
MilCAM Recon III Model Family of IR Imagers that incorporate a Class I infrared laser for Laser Range Finding (LRF). Recall # Z-0937-2009
CODE
n/a
RECALLING FIRM/MANUFACTURER
Flir Systems, Inc., North Billerica, MA, by letter on March 28, 2009. Firm initiated recall is complete.
REASON
LRF models were sold to non-DoD customers prior to certification and reporting as required in Title 21 of the Code of Federal Regulations, Subchapter J, Parts 1000 - 1050 (21 CFR 1000 - 1050). A filter defect allows transmission of laser energy such that the affected LRF would be Class 3B laser product, however the product is reported to CDRH as a Class I product.
VOLUME OF PRODUCT IN COMMERCE
120 units
DISTRIBUTION
Nationwide
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PRODUCT 
MilCAM Recon III, Family of IR Imagers that incorporates a Class IIIb infrared laser pointer. Recall # Z-1223-2009
CODE
Serial numbers: AH0260 AH0264 AH0259 AH0257 AH0250 AH0261 AH0258 AH0467 AH0413 AH0414 AH0415 AH0416 AH0417 AH0450 AH0451 AH0456 AH0458 AH0459 AH0460 AH0462 AH0464 AH0465 AH0461 AH0453 AH0454 AH0452 AH0455 AH0457 AH0463 AH0414 AH0466 AH0468 AH0599 AH0600 AH0606 AH0601 AH0608 AH0597 AH0596 AH0602 AH0470 AH0595 AH0607 AH0471 AH0603 AH0469 AH0609 AH0598 AH0604 AH0605 AH0610 AH0613 AH0611 AH0612, and AH0614
RECALLING FIRM/MANUFACTURER
Flir Systems, Inc., North Billerica, MA, by letter on April 17, 2009. Firm initiated recall is complete.
REASON
MilCAM Recon III models were sold to non-DoD customers prior to certification and reporting as required in Title 21 of the Code of Federal Regulations. Conditions of sale were not stated in variance approval letters issued for similar laser products.
VOLUME OF PRODUCT IN COMMERCE
58 units
DISTRIBUTION
Nationwide
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PRODUCT 
1) GE Healthcare CT Systems Table Model Number 2225283 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems. Recall # Z-1257-2009;

2) GE Healthcare CT Systems Table Model Number 2271242 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems. Recall # Z-1258-2009;

3) GE Healthcare CT Systems Table Model Number 2269165 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems. Recall # Z-1259-2009
CODE
1) All tables and serial numbers associated with Model Number 2225283;
2) All tables and serial numbers associated with Model Number 2271242;
3) Tables, with associated serial numbers, built before FW20, 2002
RECALLING FIRM/MANUFACTURER
GE Medical Systems, LLC, Waukesha, WI, by visit beginning April 27, 2009. Firm initiated recall is ongoing.
REASON
Failure to provide the certification label required by 21 CFR 1010.2.
VOLUME OF PRODUCT IN COMMERCE
1179 units
DISTRIBUTION
Nationwide
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PRODUCT 
Celex/GE Precision MPi, REF no.: 02980000 Is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including: R&F, radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies. Recall # Z-1658-2009
CODE
Serial Numbers: 507003, 507004, 507005, 510004, 510009, 510010, 513001, 513003, 513007, 518001, 518002, 518004, 518005, 518006, 518011, 518013, 518014, 518015, 518017, 518018, 518020, 522001, 522002, 522003, 522004, 522005, 522006, 522008, 522009, 522012, 522014, 522015, 522016, 522018, 522019, 536001, 536002, 536003, and 536007
RECALLING FIRM/MANUFACTURER
NRT - Nordisk Rontgen Teknik A/S, Hasselager, Denmark, by letter dated May 1, 2009. Firm initiated recall is ongoing.
REASON
The GE Precision MPi is in violation with 21 CFR Part 1020.32 requiring a signal audible to the fluoroscopist to sound for each passage of 5 minutes of fluoroscopic irradiation time during an examination or procedure.
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION
Nationwide
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PRODUCT 
1) GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. Recall # Z-1687-2009;

2) Innova 3100, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. Recall # Z-1688-2009;

3) GE Innova 3100-IQ, Cardiovascular Imaging System, (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. Recall Z-1689-2009;

4) GE Innova 4100, (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. Recall # Z-1690-2009;

5) GE Innova 4100-IQ, (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. Recall # Z-1691-2009
CODE
1) Serial Numbers: 00000549014BU9 00000559113BU6 00000468132BU6 00000550787BU6 00000476562BU4 00000504278BU3 00000541267BU1 00000504213BU0 00000543793BU4 00000471654BU4 00000493726BU4 00000484054BU2 00000480361BU5 00000491716BU7 00000480141BU1 00000478109BU2 00000551073BU0 00000542139BU1 00000548596BU6 00000568569BU8 00000492255BU5 00000548503BU2 00000545486BU3 00000552387BU3 00000485315BU6 00000558901BU5 00000466659BU0 00000470059BU7 00000466984BU2 00000572055BU2 00000505180BU0 00000499524BU7 00000473103BU0 00000544810BU5 00000566379BU4 00000566835BU5 00000499523BU9 00000500515BU0 00000571259BU1 00000472240BU1 00000499386BU1 00000559819BU8 00000551081BU3 00000484361BU1 00000564503BU1 00000549262BU4 00000551080BU5 00000520192BU6 00000490443BU9 00000476249BU8 00000461599BU3 00000533867BU8 00000537820BU3 00000054776BU4 00000548841BU6 00000543266BU1 00000551641BU4 00000512954BU9 00000493888BU2 00000518354BU6 00000553078BU1 00000469582BU1 00000545962BU3 00000485032BU7 00000566594BU8 00000468193BU8 00000570102BU4 00000569024BU3 00000545490BU5 00000543797BU5 00000509365BU3 00000560479BU8 00000479585BU2 00000548595BU8 00000543796BU7 00000531109BU7 00000552382BU4 00000460641BU4 00000460969BU9 00000550786BU8 00000504275BU9 00000493887BU4 00000563630BU3 00000552746BU0 00000563628BU7 00000531111BU3 00000569371BU8 00000513959BU7 00000466830BU7 00000473099BU0 00000479758BU5 00000479243BU8 00000477389BU1 00000500616BU8 00000509440BU4 00000566146BU7 00000491709BU2 00000543076BU4 00000546168BU6 00000561529BU9 00000509441BU2 00000491706BU8 00000562976BU1 00000553276BU7 00000477893BU2 00000546167BU8 00000560911BU0 00000515486BU9 00000537597BU7 00000564215BU2 00000538055BU5 00000493727BU2 00000562518BU1 00000508010BU6 00000559585BU5 00000560474BU9 00000552390BU7 00000483161BU6 00000559233BU2 00000479216BU4 00000465375BU4 00000483162BU4 000000006U0007 00000533870BU2 00000552055BU6 00000556787BU0 00000500612BU7 00000567993BU1 00000569026BU8 00000567352BU0 00000567338BU9 00000509439BU6 00000464559BU4 00000463841BU7 00000479937BU5 00000499840BU7 00000567334BU8 00000493725BU6 00000544289BU2 00000560909BU4 00000552385BU7 00000469466BU7 00000543169BU7 00000542273BU8 00000467455BU2 00000492106BU0 00000546157BU9 00000492922BU0 00000567350BU4 00000552386BU5 00000565106BU2 00000517924BU7 00000547292BU3 00000538034BU0 00000513294BU9 00000471760BU9 00000548165BU0 00000471487BU9 00000468168BU0 00000476109BU4 00000523240BU0 00000461379BU0 00000542138BU3 00000478363BU5 00000504277BU5 00000480315BU1 00000480140BU3 00000479701BU5 00000476013BU8 00000492457BU7 00000513296BU4 00000538053BU0 00000545052BU3 00000541271BU3 00000477463BU4 00000511494BU7 00000548592BU5 00000551634BU9 00000468192BU0 00000469465BU9 00000470060BU5 00000545048BU1 00000523777BU1 00000545046BU5 00000461266BU9 00000523086BU7 00000516769BU7 00000538572BU9 00000537027BU5 00000540176BU5 00000553269BU2 00000491032BU9 00000543265BU3 00000543798BU3 00000548598BU2 00000540174BU0 00000544495BU5 00000542274BU6 00000510844BU4 00000541966BU8 00000476725BU7 00000492136BU7 00000569021BU9 00000513958BU9 00000530413BU4 00000549261BU6 00000543799BU1 00000560472BU3 00000478275BU1 00000492243BU1 00000476685BU3 00000545588BU6 00000465560BU1 00000543269BU5 00000509136BU8 00000537449BU1 00000523241BU8 00000491172BU3 00000551444BU3 00000522942BU2 00000564216BU0 00000008C20126 00000565614BU5 00000563636BU0 00000551443BU5 and 00000545589BU4;

2) Serial Numbers: 00000529517BU5 00000458534BU5 00000435031BU0 00000566382BU8 00000512956BU4 00000550134BU1 00000549706BU0 00000523132BU9 00000537463BU2 00000547770BU8 00000446090BU3 00000491058BU4 00000537465BU7 00000476260BU5 00000530412BU6 00000555080BU1 00000437215BU7 00000465048BU7 00000482707BU7 00000541969BU2 00000488003BU5 00000545420BU2 00000556280BU6 00000484393BU4 00000544285BU0 00000523134BU5 00000477394BU1 00000482419BU9 00000551636BU4 00000509132BU7 00000568027BU7 00000543272BU9 00000545590BU2 00000548338BU3 00000482661BU6 00000440229BU3 00000521654BU4 00000544808BU9 00000565460BU3 00000520189BU2 00000512758BU4 00000509817BU3 00000545421BU0 00000482188BU0 00000477767BU8 00000557461BU1 00000445301BU5 00000543795BU9 00000424103BU0 00000545419BU4 00000454181BU9 00000449819BU2 00000463520BU7 00000552743BU7 00000548601BU4 00000442172BU3 00451726BU4BU8 00000497601BU5 00000438668BU6 00000492274BU6 00000505219BU6 00000567995BU6 00000571256BU7 00000465766BU4 00000466810BU9 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3) Serial Numbers: 00000529517BU5 00000458534BU5 00000435031BU0 00000566382BU8 00000512956BU4 00000550134BU1 00000549706BU0 00000523132BU9 00000537463BU2 00000547770BU8 00000446090BU3 00000491058BU4 00000537465BU7 00000476260BU5 00000530412BU6 00000555080BU1 00000437215BU7 00000465048BU7 00000482707BU7 00000541969BU2 00000488003BU5 00000545420BU2 00000556280BU6 00000484393BU4 00000544285BU0 00000523134BU5 00000477394BU1 00000482419BU9 00000551636BU4 00000509132BU7 00000568027BU7 00000543272BU9 00000545590BU2 00000548338BU3 00000482661BU6 00000440229BU3 00000521654BU4 00000544808BU9 00000565460BU3 00000520189BU2 00000512758BU4 00000509817BU3 00000545421BU0 00000482188BU0 00000477767BU8 00000557461BU1 00000445301BU5 00000543795BU9 00000424103BU0 00000545419BU4 00000454181BU9 00000449819BU2 00000463520BU7 00000552743BU7 00000548601BU4 00000442172BU3 00451726BU4BU8 00000497601BU5 00000438668BU6 00000492274BU6 00000505219BU6 00000567995BU6 00000571256BU7 00000465766BU4 00000466810BU9 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00000493235BU6 00000559582BU2 00000470052BU2 00000417617BU8 and 00000432299BU6
RECALLING FIRM/MANUFACTURER
GE Healthcare, Waukesha, WI, by letter dated November 3, 2008. Firm initiated recall is ongoing.
REASON
During a Maximum Air Kerma Rate (AKR) calibration procedure check, GE Healthcare found the AKR calibration procedure does not exactly reflect the worst-case clinical usage of the product. This may result, when using large Equivalent Patient Thickness and in some rare cases of system/set-up combinations, in a non-compliance with 21 CFR 1020.32. The non-compliance may exceed the regulatory standard limit of 88mGy/min (10 R/min) by 6% (90.6 4mGy/min or 10.63R/min). The system works properly until the point where the maximum Air Kerma Rate is reached (88mGy/min or 10R/min).
VOLUME OF PRODUCT IN COMMERCE
929 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Jejunal Feeding Set, Product Order number FLOWJ-9-20. This device is used for percutaneous endoscopic placement to provide internal nutrition to patients requiring nutritional support. Recall # Z-1910-2009
CODE
Lot number W2676476
RECALLING FIRM/MANUFACTURER
Cook Endoscopy, Winston Salem, NC, by letter on July 24, 2009. Firm initiated recall is complete.
REASON
The English only version of the Patient Care Manuals that accompany the device were shipped to a medical facility in Italy.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Italy
___________________________________
PRODUCT 
iPulse Circulatory Support System Catalog number: 0036-0010 The iPulse System Console is a multi-purpose mechanical circulatory support system used to support patients suffering from acute cardiovascular failure. The iPulse console can be used to drive exclusively one of two classes of therapeutic devices: either pneumatically actuated Ventricular Assist Devices (VADs) for total circulatory support, or (i.e., non-simultaneously) an intra-aortic balloon (IAB) catheter for counter-pulsation therapy. Recall # Z-1931-2009
CODE
Serial numbers: SC1000, SC1001, SC1003 - SC1010, SC1014 - SC1023, SC1025 - SC1070, SC1072 - SC1081, SC1083, SC1084, and SC1089
RECALLING FIRM/MANUFACTURER
Abiomed, Inc., Danvers, MA, by letter on April 8, 2009. Firm initiated recall is complete.
REASON
iPulse Console SC1035 displayed a "Low Pressure / Low Flow" alarm and stopped pumping during patient transport in battery operation.
VOLUME OF PRODUCT IN COMMERCE
79 units
DISTRIBUTION
Nationwide, Germany, Greece, Italy, Latvia, Spain, and Turkey
___________________________________
PRODUCT 
ACT3020 Advanced Cutting technology (ACT) Twist Drill 3.0mm(D) X 20mm(L). Made in Switzerland. Twist drill for preparation of osteotomy during dental implant surgical drilling procedure. Recall # Z-1947-2009
CODE
Lot # 860172
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomet 3i, LLC, Palm Beach Gardens, FL, by letter dated June 30, 2009.
Manufacturer: Dentsply Maillefer, Ballaigues, Switzerland. Firm initiated recall is ongoing.
REASON
Some of the packages of ACT3020, drills may actually contain an ACT3220 drill.
VOLUME OF PRODUCT IN COMMERCE
29 units
DISTRIBUTION
Nationwide, Korea, Netherlands, Taiwan, United Kingdom
___________________________________
PRODUCT 
BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for clinical lab use with ELx800 and ELx808 microplate readers, offers preprogrammed clinical diagnostic assays within a PC-based application. Recall # Z-2223-2009
CODE
Software versions 1.07 and lower
RECALLING FIRM/MANUFACTURER
BioTek Instruments, Inc., Winooski, VT, by letters dated March 13, 2009 and March 25, 2009. Firm initiated recall is complete.
REASON
Software design allowed false negatives to be read when wells are dark.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
MN, CA, IL, MA, MI, CA, GA, FL, AZ and TX and Peru
___________________________________
PRODUCT 
Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number: C0R36, Labeled Sterile. Disposable single-use devices indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgeries. Endoscopic instruments for surgery. Recall # Z-2226-2009
CODE
Lot Numbers:1084426 and 1085506
RECALLING FIRM/MANUFACTURER
Applied Medical Resources Corp., Rancho Santa Margarita, CA, by letter dated June 9, 2009. Firm initiated recall is ongoing.
REASON
Applied Medical is conducting a coluntary recall of two lot numbers, 1084426 and 1085506, of the 15mm Kii non-threaded optical access system, model C0R36, due to a potential weakness in the cannula tip, possibly resulting in tip breakage.
VOLUME OF PRODUCT IN COMMERCE
934 units
DISTRIBUTION
Nationwide, Australia, New Zealand, France, Canada, Norway and Great Britain
___________________________________
PRODUCT 
1) St. Jude Medical FAST-CATH Hemostasis Introducer 7F, REF 406702, Length 12 CM, Lot 6372 Max. Guidewire O.D. .038", 2010-01, Sterile EO. Used for the introduction of catheters into a vessel. Recall # Z-2228-200;

2) St. Jude Medical FAST-CATH Hemostasis Introducer 4F, REF 406709, Length 12 CM. Guidewire O.D .038", 2010-01, Sterile EO. Used for the introduction of catheters into a vessel. Recall # Z-2229-2009
CODE
1) Lot Number: 6372;
2) Lot Number: 4219
RECALLING FIRM/MANUFACTURER
St. Jude Medical, Minnetonka, MN, by letter beginning August 28, 2009. Firm initiated recall is ongoing.
REASON
St. Jude Medical has initiated a voluntary recall of two lots of Fast-Cath Hemostasis Introducers-reorder number 406709, lot number 4219 and reorder number 406702, lot number 6372. They discovered that the product lots could contain some items which have been mis-labeled with the incorrect French size. In one case, the pouch label does not correctly identify the content of the pouch. In another case, the carton label is incorrect. The pouch label indicated that the product was 4F catheter, but the contents of the pouch may be a 7F catheter. St. Jude Medical has not received any reports of injuries resulting from this mis-labeling.
VOLUME OF PRODUCT IN COMMERCE
2,490 units
DISTRIBUTION
CA, MI, PA, TN, China and Belgium
___________________________________
PRODUCT 
ZOLL R Series Defibrillator/Pacemaker/Monitor Used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. Recall # Z-2315-2009
CODE
Serial numbers: AF07F001253 AF07I002116 AF08A003438 AF08D004586 AF08F005082 AF08F005110 AF08G005269 AF08H005383 AF08I005615 AF08I005627 AF08I005646 AF08I005659 AF08I005709 AF08J005735 AF08J005757 AF08J005768 AF08J005776 AF08K005996 AF08K006000 AF08K006007 AF08K006017 AF08K006053 AF08K006102 AF08L006282 AF08L006358 AF08L006359 AF08L006397 AF08L006412 AF08L006442 AF08L006447 AF08L006457 AF08L006462 AF08L006501 AF08L006503 AF08L006508 AF08L006512 AF08L006514 AF08L006515 AF08L006516 AF08L006517 AF08L006518 AF08L006519 AF08L006520 AF08L006521 AF08L006522 AF08L006524 AF08L006528 AF08L006530 AF08L006531 AF08L006532 AF08L006533 AF08L006534 AF08L006535 AF08L006545 AF08L006546 AF08L006547 AF08L006551 AF08L006556 AF08L006558 AF08L006559 AF08L006560 AF08L006565 AF08L006568 AF08L006574 AF08L006575 AF08L006577 AF08L006578 AF08L006579 AF08L006580 AF08L006582 AF08L006583 AF08L006584 AF08L006585 AF08L006586 AF08L006587 AF08L006589 AF08L006590 AF08L006591 AF08L006592 AF08L006593 AF08L006594 AF08L006596 AF08L006598 AF08L006599 AF08L006600 AF08L006601 AF08L006603 AF08L006604 AF08L006605 AF08L006606 AF08L006607 AF08L006609 AF08L006610 AF08L006611 AF08L006612 AF08L006613 AF08L006614 AF08L006619 AF08L006620 AF08L006621 AF08L006622 AF08L006624 AF08L006625 AF08L006626 AF08L006627 AF08L006628 AF09B006680 AF09B006681 AF09B006682 AF09B006684 AF09B006685 AF09B006686 AF09B006688 AF09B006690 AF09B006709 AF09B006712 AF09B006714 AF09B006715 AF09B006716 AF09B006718 AF09B006724 AF09B006726 AF09B006727 AF09B006728 AF09B006732 AF09B006736 AF09B006737 AF09B006739 AF09B006740 AF09B006744 AF09B006745 AF09B006748 AF09B006761 AF09B006762 AF09B006765 AF09B006766 AF09B006767 AF09B006768 AF09B006770 AF09B006772 AF09B006774 AF09B006775 AF09B006776 AF09B006777 AF09B006778 AF09B006779 AF09B006780 AF09B006781 AF09B006782 AF09B006783 AF09B006784 AF09B006785 AF09B006786 AF09B006787 AF09B006789 AF09B006791 AF09B006794 AF09B006795 AF09B006798 AF09B006799 AF09B006800 AF09B006801 AF09B006802 AF09B006806 AF09B006807 AF09B006808 AF09B006809 AF09B006810 AF09B006811 AF09B006812 AF09B006813 AF09B006814 AF09B006815 AF09B006816 AF09B006818 AF09B006819 AF09B006820 AF09B006821 AF09B006824 AF09B006825 AF09B006827 AF09B006828 AF09B006830 AF09B006831 AF09B006832 AF09B006834 AF09B006836 AF09B006837 AF09B006838 AF09B006839 AF09B006840 AF09B006841 AF09B006842 AF09B006844 AF09B006845 AF09B006846 AF09B006847 AF09B006859 AF09B006860 AF09B006861 AF09C006880 AF09C006881 AF09C006883 AF09C006884 AF09C006888 AF09C006894 AF09C006895 AF09C006896 AF09C006899 AF09C006905 AF09C006912 AF09C006915 AF09C006928 AF09C006929 AF09C006930 AF09C006931 AF09C006932 AF09C006933 AF09C006934 AF09C006937 AF09C006939 AF09C006940 AF09C006942 AF09C006956 AF09C006957 AF09C006958 AF09C006959 AF09C006960 AF09C006961 AF09C006962 AF09C006964 AF09C006968 AF09C007103 AF09C007104 AF09C007106 AF09C007107 AF09C007108 AF09C007109 AF09C007110 AF09C007111 AF09C007130 AF09C007132 AF09C007194 AF09C007200 AF09C007427 AF09D007485, and AF09F007805
RECALLING FIRM/MANUFACTURER
ZOLL Medical Corporation, World Wide Headquarters, Chelmsford, MA, by letter on August 31, 2009 and on September 1, 2009. Firm initiated recall is ongoing.
REASON
Failure of Device to display ECG could delay delivery of defibrillation or pacing therapy.
VOLUME OF PRODUCT IN COMMERCE
247 units
DISTRIBUTION
Nationwide, UK, Austria, Australia,, Canada, Switzerland, Germany, France, French Guiana, Jordan, Macedonia, Netherlands, Panama, Poland, Romania, and Saudi Arabia

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT 
1) TI Cann Partl Thd Recon Screw 6.00MM x 65MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-406065. Recall # Z-2277-2009;

2) TI Cann Partl Thd Recon Screw 6.00MM x 70MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-406070. Recall # Z-2278-2009;

3) TI Cann Partl Thd Recon Screw 6.00MM x 75MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-406075. Recall # Z-2279-2009;

4) TI Cann Partl Thd Recon Screw 6.00MM x 80MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-406080. Recall # Z-2280-2009;

5) TI Cann Partl Thd Recon Screw 6.00MM x 85MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item 14-406085. Recall # Z-2281-2009;

6) TI Cann Partl Thd Recon Screw 6.00MM x 90MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-406090. Recall # Z-2282-2009;

7) TI Cann Partl Thd Recon Screw 6.00MM x 95MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-406095. Recall # Z-2283-2009;

8) TI Cannulated Screw 20MM thrd 6.5MM (d) X 85MM (L); Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number: 245846. Recall # Z-2284-2009;

9) TI Cannulated Screw 32MM thrd 7.3MM (d) X 95MM (L); Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 245958. Recall # Z-2285-2009;

10) TI Cannulated Screw 32MM thrd 7.3MM (d) X 100MM (L); Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number: 245960. Recall # Z-2286-2009;

11) TI Cannulated Screw 32MM thrd 7.3MM (d) X 120MM (L); Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 245968. Recall # Z-2287-2009;

12) TI Screw Buttress Thread 5MM (D) x 35MM (L) Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 33-345424. Recall # Z-2288-2009;

13) TI Screw Buttress Thread 6MM (D) x 65MM (L) Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 33-345534. Recall # Z-2289-2009;

14) Bone Screw 5.5MM X 45MM Bone Screw Lck-Cann, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27445. Recall # Z-2290-2009;

15) Bone Screw 5.5MM X 55MM Bone Screw Lck-Cann, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27455. Recall # Z-2291-2009;

16) Bone Screw 5.5MM X 70MM Bone Screw Lck-Cann, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 274470. Recall # Z-2292-2009;

17) Bone Screw 4.5MM X 20MM Bone Screw Lock, Rx only. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27820. Recall # Z-2293-2009;

18) Bone Screw 4.5MM X 28MM Bone Screw Lock, Rx only. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27828. Recall # Z-2294-2009;

19) Bone Screw 4.5MM X 36MM Bone Screw Lock, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27836. Recall # Z-2295-2009;

20) Bone Screw 4.5MM X 52MM Bone Screw Lck-Cann, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27852. Recall # Z-2296-2009;

21) Bone Screw .5MM X 60MM Bone Screw Lock, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27860. Recall # Z-2297-2009;

22) Bone Screw 4.5MM X 70MM Bone Screw Lock, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27870. Recall # Z-2298-2009;

23) Bone Screw4.5MM X 95MM Bone Screw Lock, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27895. Recall # Z-2299-2009;

24) Cannulated Screw Ballista Percutaneous Pedicle Screw System. 6/5 x 45MM; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 2000-3445. Recall # Z-2300-2009;

25) C-Tek Maxan Anterior Cervical Plate System; 4.0MM X 20MM Fixed Screw'; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-521520. Recall # Z-2301-2009;

26) Pediatric Femoral Nail 5.5MM (d) x 28 CM (L) Rx only, Sterile; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 24128. Recall # Z-2302-2009;

27) Pediatric Femoral Nail 5.5MM (d) x 30 CM (L) Rx only, Sterile; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 24130. Recall # Z-2303-200;

28) Pediatric Femoral Nail 5.5MM (d) x 32 CM (L) Rx only, Sterile; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 24132. Recall # Z-2304-2009;

29) Pediatric Femoral Nail 5.5MM (d) x 36 CM (L) Rx only, Sterile; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 24136. Recall # Z-2305-2009;

30) Fixed Closed Screw, 6.5mm (D) x 40mm (L), Made in USA; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog number 6147. Recall # Z-2306-2009;

31) Fixed Open Screw (TI); 7.0MM (D) x 30MM (L); Made In USA. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog Number 7140. Recall # Z-2307-2009;

32) Fixed Closed Screw (Ti); 5.0MM (D) x 25MM (L); Made in USA. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog Number 7155. Z-2308-2009;

33) Fixed Closed Screw (Ti); 6.0MM (D) x 40 MM (L) Made In USA. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog Number 7162. Recall # Z-2309-2009;

34) Bone Screw 6MM (D) x 35MM (L) Telescopic Plate Spacer, Thoracolumbar Spinal System Made in USA. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog Number 1300-0635. Recall # Z-2310-2009;

35) Bone Screw 7MM (D) x 35 MM (L) Telescopic Plate Spacer Thoracolumbar Spinal System; Made in USA. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog Number: 1300-0735. Recall # Z-2311-200;

36) Multi-Axial Screw (TI); 8.00MM (D) x 70MM(L) W/Collar; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog Number 6588. Recall # Z-2312-2009
CODE
1) Lot number 517260;
2) Lot number 517270;
3) Lot number 517280;
4) Lot number 517290;
5) Lot number 517300;
6) Lot number 517320;
7) Lot number 517330;
8) Lot number 665220;
9) Lot number 668110;
10) Lot number 688120;
11) Lot number 688130;
12) Lot numbers 733230, 733240, 733250;
13) Lot numbers 599000, 616450, 618520;
14) Lot number 708310;
15) Lot number 721730;
16) Lot number 741840;
17) Lot number 697550;
18) Lot number 697560;
19) Lot number 716900;
20) Lot number 696110;
21) Lot number 717040, 721480;
22) Lot numbers 741860, 744730;
23) Lot number 717050;
24) Lot numbers 705610, 710680, 741900;
25) Lot number 840070;
26) Lot numbers 612010, 658220;
27) Lot number 557430;
28) Lot number 557440;
29) Lot number 798630;
30) Packaging Lot # 885870, Unpackaged Lot # 605992;
31) Packaging Lot # 825200/894010, Unpackaged lot #605121;
32) Packaging Lot # 641010, Unpackaged Lot 605122;
33) Packaging Lot # 723910, Unpackaged Lot # 605125;
34) Packaging Lot: 691780, Unpackaged lot: 605339;
35) Packaging Lot: 703250, Unpackaged lot 605340;
36) Packaging Lot: 651150, Unpackaged lot 605119
RECALLING FIRM/MANUFACTURER
EBI, L.P., Parsippany, NJ, by letters dated March 29, 2009, April 2, 2009 and April 16, 2009, e-mail on May 22, 2009, and June 19, 2009. Firm initiated recall is ongoing.
REASON
Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
VOLUME OF PRODUCT IN COMMERCE
708 units
DISTRIBUTION
Nationwide, Brazil, Colombia, Denmark, Germany, Finland, Greece, Italy, Japan, The Netherlands, Switzerland, Sweden, Portugal, Spain, United Kingdom, Saudi Arabia, and Trinidad

END OF ENFORCEMENT REPORT FOR DECEMBER 30, 2009
 

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