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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 Legacysee related information
Date Initiated by FirmOctober 12, 2006
Date PostedNovember 22, 2006
Recall Status1 Terminated 3 on December 10, 2007
Recall NumberZ-0209-2007
Recall Event ID 36599
510(K)NumberK963148 
Product Classification knee prosthesis - Product Code JWH
ProductZimmer 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
ActionConsignees 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 Commerce18
DistributionNationwide.
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.
510(K) Database510(K)s with Product Code = JWH
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