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

• Date Initiated by Firm: November 25, 2008
• Date Posted: January 09, 2009
• Recall Status: Terminated on November 12, 2009
• Recall Number: Z-0871-2009
• Recall Event ID: 50546
• 510(K)Number: K023528
• Product Classification: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis - 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 IN 46580-2746
• For Additional Information Contact: 800-613-6131
• 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: 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 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