The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T
FDA device recall Z-1379-05 · posted 2005-08-18 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- Implant was identified incorrectly at the time of manufacture and then laser etched with the incorrect size information.
- Action taken
- All consignees were notified by letter on 06/02/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 41
- Distribution
- Distributed to 15 Domestic Consignees 4 Foreign Distributors.
- Date initiated
- 2005-06-02
- Date posted
- 2005-08-18
- Date terminated
- 2008-10-24
- Location
- Gainesville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS (K932776) | Exactech, Inc. | 1994-10-20 |