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Medical Devices

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ConMed Linvatec - Power Pro Handpieces

Recall Class: Class I
Date Recall
Initiated:		 July 31, 2009
Product: Power Pro, Power ProMax, and MPower 1 Handpieces
Catalog Numbers Serial Numbers
Power PRO 5100
Power PRO 5100M
Power PRO 5200
Power PRO 5200M
Power PRO 5250
Power PRO 5250M
Power PRO 5300
Power PRO 5300M
Power PRO 5400
Power PRO 5400M
Power PRO 6200
Power PRO 6202
Power PRO 6300
Power PRO 6400
Power PRO 6450

The serial numbers affected by this recall
are included in this attachment.

Attachment: Serial Numbers (Excel, 1213kb)

These handpieces were manufactured from March 26, 2002 through May 31, 2008 and distributed from March 29, 2002 through June 24, 2009.

See related Linvatec Class I recall
Use: These devices are powered surgical handpieces in which a number of surgical tools (such as drills, blades, and small cutting devices) can be attached and are used during orthopedic surgical procedures.
Recalling Firm: Linvatec Corporation doing business as (dba) ConMed Linvatec
11311 concept Boulevard
Largo, Florida 33773-4908
Reason for Recall: The device has a switch problem where it may self-activate without pushing the trigger, continues running after releasing the trigger, and runs in unintended directions.
Public Contact:

ConMed Linvatec Customer Service
1-800-237-0169
Monday-Friday, 7 AM to 7 PM Eastern Time

For more information, see Useful Links below.
FDA District: Florida
FDA Comments:

The company sent a letter to their distributors/customers with instructions to:

  • notify additional customers identified by the distributors.
  • apply supplied label to the identified handpieces by specific serial number.
  • stop using the device if it self-activates and return to the company for preventive maintenance.
  • follow the company's preventive maintenance schedule located in the user manual.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Useful Links:
    
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