Foundation Knee System, non-porous Femur Size 8, Right
FDA device recall Z-1069-03 · posted 2003-07-30 · Terminated
Recall details
- Recalling firm
- Encore Medical, LP
- Reason for recall
- Product container was labeled incorrectly indicating left femur instead of right.
- Action taken
- The firm recalled non-implanted devices. The firm initiated the recall on 04/23/2003 via phone to sales representatives and foreign distributors.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 14 unimplanted units
- Distribution
- PA, TX, MA, FL, NV, AZ, and France and Saudi Arabia
- Date initiated
- 2003-04-24
- Date posted
- 2003-07-30
- Date terminated
- 2003-07-29
- 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 (K923277) | Encore Orthopedics, Inc. | 1993-02-09 |