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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer NexGen Complete Knee Solution Legacy Knee Posterior Stabilized LPSFlex Femoral Component

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 Class 2 Device Recall Zimmer NexGen Complete Knee Solution Legacy Knee Posterior Stabilized LPSFlex Femoral Componentsee related information
Date Initiated by FirmApril 17, 2009
Date PostedJune 25, 2009
Recall Status1 Terminated 3 on November 12, 2009
Recall NumberZ-1520-2009
Recall Event ID 52003
PMA NumberP060037 
Product Classification Knee Prosthesis - Product Code NJL
ProductZimmer NexGen Complete Knee Solution Legacy Knee - Posterior Stabilized LPS-Flex Femoral Component Precoat, Size D left , sterile, Zimmer, Warsaw, IN; REF 00-5960-014-51.
Code Information Lot 61208295.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation.
FDA Determined
Cause 2		Employee error
ActionConsignees were notified by phone beginning on 4/17/09 and email and letter notifications were sent on 4/22/09. A dear surgeon letter entitled Urgent: Medical Device Recall, dated April 28, 2009, is being sent to implanting surgeons recommending patient monitoring. Consignees are to return the response form indicating their receipt of the notification. Questions or concerns should be directed to (800) 846-4637 or www.zimmer.com.
Quantity in Commerce5
DistributionWorldwide Distribution -- USA including states of Arizona, California, Colorado, Hawaii, Illinois, Indiana, Michigan, Minnesota, Mississippi, New Jersey, New Mexico, New York, Ohio, Oregon, and Pennsylvania and country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = NJL
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