Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented
FDA device recall Z-0347-05 · posted 2004-12-23 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- Implant was identified incorrectly at the time of manufacture and was then labeled and distributed with the incorrect size information.
- Action taken
- A recall letter was sent to all customers on November, 2, 2004 recalling all 21 units. These implants will be quarantined and then returned to the supplier for disposal when all 21 implants are received.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 21 implants
- Distribution
- Distributed to New Jersey, Florida, Minnesota, New York, Maryland, Texas and the United Kingdom
- Date initiated
- 2004-11-11
- Date posted
- 2004-12-23
- Date terminated
- 2012-05-03
- 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 |
|---|---|---|
| EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS (K933610) | Exactech, Inc. | 1995-01-17 |