Recall Z-0985-03 ยท MDM Instrument, Manual, Surgical, General Use
Ethicon Endo-Surgery
Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples with integral knife, Product No. TCT10, staple size: 3 mm x 4.5 mm.
| Date | Jul 8, 2003 (initiated May 21, 2003) |
| Status | Terminated |
| Reason | The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly. |
| Root cause | Other |
| Action | The firm contacted their customers by FedEx on 5/21/2003. |
| Quantity | 8 units |
| Distribution | The product was shipped to hospitals and distributors located nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020779 | PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS Ethicon Endo-Surgery, Inc., Jun 5, 2002 |