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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 surfacesee related information
Date Initiated by FirmDecember 12, 2008
Date PostedJanuary 23, 2009
Recall Status1 Terminated 3 on November 12, 2009
Recall NumberZ-0886-2009
Recall Event ID 50544
Product Classification Template for clinical use - Product Code HWT
ProductZimmer 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
ActionZimmer 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 Commerce131 of both products.
DistributionNationwide, Canada, Denmark, Finland, Germany, Poland, Spain, Sweden and United Kingdom.
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.
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