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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 Component see related information
Date Initiated by Firm April 17, 2009
Date Posted June 25, 2009
Recall Status1 Terminated 3 on November 12, 2009
Recall Number Z-1521-2009
Recall Event ID 52003
PMA Number P060037 
Product Classification Knee Prosthesis - Product Code NJL
Product Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS-FLEX Femoral Component Option Size D Left, sterile, Zimmer, Warsaw, IN; REF 00-5964-014-51.
Code Information Lot 61219714.
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
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 1
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 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 Database PMAs with Product Code = NJL and Original Applicant = ZIMMER, INC.
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