FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P.
FDA device recall Z-2466-2008 · posted 2008-09-29 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Complaints received regarding the fracture of the Nitronic 60 screw on the Tibial Fixed Impactor during surgery.
- Action taken
- Recall notification sent via letter starting on 08/04/07. Consignees asked to quarantine and return affected devices. Contact Encore Medical, Lp at 1-512-834-6330 for assistance.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 68 units.
- Distribution
- FL and TX and OUS: Japan.
- Date initiated
- 2008-08-04
- Date posted
- 2008-09-29
- Date terminated
- 2009-08-03
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FOUNDATION KNEE SYSTEM TIBIAL COMPONENT (K970031) | Encore Orthopedics, Inc. | 1997-04-02 |
| FOUNDATION KNEE AUGMENTATION BLOCKS (K941306) | Encore Orthopedics, Inc. | 1995-02-08 |
| FOUNDATION KNEE SYSTEM (K923277) | Encore Orthopedics, Inc. | 1993-02-09 |