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U.S. Department of Health and Human Services

Class 2 Device Recall NexGen Complete Knee Solution Stemmed Tibial Component

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 Class 2 Recall
NexGen Complete Knee Solution Stemmed Tibial Component
see related information
Date Posted October 21, 2010
Recall Status1 Terminated on October 23, 2010
Recall Number Z-0119-2011
Recall Event ID 56701
Premarket Notification
510(K) Number
K933785 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product NexGen® Complete Knee Solution Stemmed Tibial Component Precoat Size 6, REF 00-5980-047-02, Sterile, Zimmer, Warsaw, IN. Intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component and is indicated for cemented use only.
Code Information Lot Number: 61246477.
Recalling Firm/
Manufacturer
Zimmer Inc.
1800 W Center St
Warsaw, Indiana 46580-2304
Manufacturer Reason
for Recall
Zimmer had determined that two lots of these tibial implants have incorrectly positioned or missing flange plugs that were not seated in the device upon receipt to the customer. A missing flange plug could lead to a delay of surgery or possibility of wear leading to more surgery.
FDA Determined
Cause 2
TRAINING: Employee Error
Action The firm sent an URGENT MARKET WITHDRAWAL to its sales force and distributors on 1/26/2010. The letter identifies the affected product and explains the reason for the Market Withdrawal. The letter also explains the clinical implications and instructs consignees to locate any unused devices and quarantine them immediately. A physical count should be carried out of all affected devices and recorded on the Inventory Return Certification Form that's included with the letter. A copy of the letter should be faxed to Zimmer, Inc. and the affected product should be returned along with the form to the firm.
Quantity in Commerce 61 untis
Distribution Worldwide Distribution -- US, Canada, Singapore Australia, and India.
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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ZIMMER, INC.
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