Encore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric Blvd., Austin
FDA device recall Z-1566-05 · posted 2005-09-21 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Incorrect alignment markings or no markings at all on a reverse shoulder prosthesis unit.
- Action taken
- Recall was initiated by letter to sales agents on 07/28/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 93 primary units and 56 revision units
- Date initiated
- 2005-07-28
- Date posted
- 2005-09-21
- Date terminated
- 2007-04-19
- 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 REVERSE SHOULDER PROSTHESIS (K041066) | Encore Medical L.P. | 2005-03-24 |