Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular surface, Size Blue, 14 MM Height, n
FDA device recall Z-0885-2009 · posted 2009-01-23 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- Some 12 mm thick devices may have been etched and packaged as 14 mm thick, and vice versa.
- Action taken
- 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
- Status
- Terminated
- Product code
- HWT
- Quantity affected
- 131 of both products.
- Distribution
- Nationwide, Canada, Denmark, Finland, Germany, Poland, Spain, Sweden and United Kingdom.
- Date initiated
- 2008-12-12
- Date posted
- 2009-01-23
- Date terminated
- 2009-11-12
- Location
- Warsaw, IN
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