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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional Articular surface

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  Class 2 Device Recall Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional Articular surface see related information
Date Initiated by Firm December 12, 2008
Date Posted January 23, 2009
Recall Status1 Terminated 3 on November 12, 2009
Recall Number Z-0886-2009
Recall Event ID 50544
Product Classification Template for clinical use - Product Code HWT
Product Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular surface, Size Blue, 12 MM Height, nonsterile, Zimmer, Warsaw, IN; REF 5971-50-12.
Used during total knee arthroplasty surgery to determine the required thickness of the tibial bearing surface to be implanted. Reusable, non-implantable.
Code Information Lots 61007188, 60987590, 60969807, 60976981 and 60976982.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		 Some 12 mm thick devices may have been etched and packaged as 14 mm thick, and vice versa.
FDA Determined
Cause 2		 Employee error
Action Zimmer sales force and distribution sites were notified of the recall via email on 12/15/08 and instructed to inventory, return the affected products and to provide a copy of the recall letter to those customers to whom they had further distributed the products. The 'Urgent: Device Recall" letter dated 12/12/08, described the problem and the potential risks. For additional information, contact Zimmer, Inc., at 1-800-613-6131.
Quantity in Commerce 131 of both products.
Distribution Nationwide, Canada, Denmark, Finland, Germany, Poland, Spain, Sweden and United Kingdom.
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.
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