NexGen Complete Knee Solution Stemmed Tibial Component Precoat Size 6, REF 00-5980-047-02, Sterile, Zimmer, Warsaw, IN.
FDA device recall Z-0119-2011 · posted 2010-10-21 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- Zimmer had determined that two lots of these tibial implants have incorrectly positioned or missing flange plugs that were not seated in the device upon receipt to the customer. A missing flange plug could lead to a delay of surgery or possibility of wear leading to more surgery.
- Action taken
- The firm sent an URGENT MARKET WITHDRAWAL to its sales force and distributors on 1/26/2010. The letter identifies the affected product and explains the reason for the Market Withdrawal. The letter also explains the clinical implications and instructs consignees to locate any unused devices and quarantine them immediately. A physical count should be carried out of all affected devices and recorded on the Inventory Return Certification Form that's included with the letter. A copy of the letter should be faxed to Zimmer, Inc. and the affected product should be returned along with the form to the firm.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 61 untis
- Distribution
- Worldwide Distribution -- US, Canada, Singapore Australia, and India.
- Date initiated
- 2010-01-26
- Date posted
- 2010-10-21
- Date terminated
- 2010-10-23
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEXT GENERATION KNEE SYSTEM (K933785) | Zimmer, Inc. | 1995-01-30 |