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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer NexGen Legacy

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  Class 2 Device Recall Zimmer NexGen Legacy see related information
Date Initiated by Firm October 12, 2006
Date Posted November 22, 2006
Recall Status1 Terminated 3 on December 10, 2007
Recall Number Z-0209-2007
Recall Event ID 36599
510(K)Number K963148  
Product Classification knee prosthesis - Product Code JWH
Product Zimmer NexGen Complete Knee Solution Legacy Knee Tibial Component, 3 degree, fluted, size 4, stemmed option, for cemented use only, tivanium TI-6AL-4V alloy/UHMWPE, sterile; Catalog no. 05-5998-038-02.
Code Information Lot 60472442; exp. May 2011.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-846-4637
Manufacturer Reason
for Recall		 The polyethylene tibial articular surface may not lock into some of the tibial plates.
FDA Determined
Cause 2		 Other
Action Consignees were notified by a letter dated 10/12/06 and sent to operating room supervisors and Zimmer distributors to cease using the product and to return it to the firm.
Quantity in Commerce 18
Distribution Nationwide.
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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ZIMMER, INC.
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