Recall Z-0961-04 ยท GDW Staple, Implantable
United States Surgical
Auto SutureTA 45 Reloadable Stapler,Single Patient Use, 3.5mm DST Series Ref: TA4535S
| Date | Jul 20, 2004 (initiated May 5, 2004) |
| Status | Terminated |
| Reason | Stapler may clamp without the staples being fired into the tissue |
| Root cause | Other |
| Action | United States Surgical notiied direct accounts by letter dated 5/5/04. Accounts are requested to inventory and quarantine product for return to USS. |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013860 | AUTO SUTURE SURGICAL STAPLES United States Surgical, A Division of Tyco Healthc, Dec 19, 2001 |