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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer NaturalKnee II System Modular Cemented Tibial Baseplate

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 Class 2 Recall
Zimmer NaturalKnee II System Modular Cemented Tibial Baseplate
see related information
Date Posted January 09, 2009
Recall Status1 Terminated on November 12, 2009
Recall Number Z-0871-2009
Recall Event ID 50546
Premarket Notification
510(K) Number
K023528 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 3, For cemented use only, sterile, Zimmer, Warsaw, IN; REF 6420-01-230. The modular cemented tibial baseplate is indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact. These are single use implantable devices sold sterile.
Code Information Lot 60830979.
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw, Indiana 46580-2746
Manufacturer Reason
for Recall
Sterility compromised: Lack of assurance of sterility, as a corner flap of the sterile barrier packaging on the inner cavity may be trapped in the seal of the barrier packaging for the outer cavity and the seal integrity of the outer sterile barrier cannot be assured.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Zimmer distributors were notified by email of letter dated 11/25/08 on 11/25/08. This letter is entitled "URGENT: DEVICE RECALL." Secondary consignees/user accounts were notified by a copy of the 11/25/08 letter, which was sent on or before 12/05/08. Consignees were instructed to stop using the product and to return it to Zimmer. For further information, please contact Zimmer, Inc. by telephone by dialing 800-613-6131.
Quantity in Commerce 10
Distribution Nationwide Distribution --- including states of Arkansas, Florida, Michigan, North Carolina, New York and Wisconsin.
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 = CENTERPLUS ORTHOPEDICS, INC
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