HA Hip Stem, cementless
FDA device recall Z-1128-04 · posted 2004-07-22 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Hip stem product was mis-labeled with wrong size.
- Action taken
- Firm sent letter of notification to consignee on 6/30/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 3 units
- Distribution
- Deerfield Beach, FL
- Date initiated
- 2004-06-30
- Date posted
- 2004-07-22
- Date terminated
- 2004-10-21
- 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 |
|---|---|---|
| ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA (K993943) | Encore Orthopedics, Inc. | 2000-02-04 |