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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 LPS Femoral Component

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 Class 2 Recall
Zimmer NexGen Complete Knee Solution Legacy Knee Posterior Stabilized LPS Femoral Component
see related information
Date Posted June 25, 2009
Recall Status1 Terminated on November 12, 2009
Recall Number Z-1523-2009
Recall Event ID 52003
Premarket Approval
PMA Number
P060037
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing - Product Code NJL
Product Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS Femoral Component Option Size D Left, sterile, Zimmer, Warsaw, IN; REF 00-5996-014-51.
Code Information Lot 61207901.
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw, Indiana 46580-2746
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
TRAINING: Employee Error
Action Consignees 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 Commerce 10
Distribution Worldwide 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 Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = NJL and Applicant = ZIMMER, INC.
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