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Terminated

Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular surface, Size Blue, 14 MM Height, nonsterile, Zimmer, Warsaw, IN; REF 5971-50-14. Used during total knee arthroplasty surgery to determine the required thickness of the tibial bearing surface to be implanted. Reusable, non-implantable.

FDA Recall Z-0885-2009 · Posted 2009-01-23

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeHWT
Date Initiated2008-12-12
Date Terminated2009-11-12
Product Quantity131 of both products.

Reason for Recall

Some 12 mm thick devices may have been etched and packaged as 14 mm thick, and vice versa.

Firm 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.

Root Cause

Employee error

Distribution Pattern

Nationwide, Canada, Denmark, Finland, Germany, Poland, Spain, Sweden and United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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