Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNE
FDA device recall Z-0927-06 · posted 2006-06-02 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- An implant within a lot of finned tibial trays manufactured at Exactech was not made to specification. The locking cavity in the tibial tray was not fully machined thus preventing the tibial insert from locking in place.
- Action taken
- Each consignee contacted by mail 12/19/2005, and asked to return the product to Exactech. The returned product will be quarantined and evaluated.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 14 implants from manufactured lot
- Distribution
- Distributed domestically to Alabama and Louisiana, and internationally to Spain, Germany and Greece.
- Date initiated
- 2005-12-19
- Date posted
- 2006-06-02
- Date terminated
- 2012-06-29
- 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 |