Recall Z-0953-03 ยท FWZ Operating Room Accessories Table Tray
The OR Group,Inc.
Allen Medical Systems PAL Pro Stirrups Catalog Number: A-10051-A1
| Date | Jun 27, 2003 (initiated Jun 2, 2003) |
| Status | Terminated |
| Reason | Foot Stirrups may detach from mount when user is locking system |
| Root cause | Other |
| Action | The OR Group notifed the accounts by letter sent Air Borne on 6/6/03 advising users to return the stirrups. The firm will inspect and repair the returned units. The firm expanded the recall to include units manufactured between August 02 and May 03. Recall letters were issued on 9/18/03 via Fed'X with instructions to test and identify the device for correct measurement. |
| Quantity | 460 units |
| Distribution | Nationwide Foreign: Australia, Korea, Italy, Hong Kong, Ireland, Czech republic, South Africa, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.