Recall Z-0096-2007 ยท GEJ Carrier, Ligature
Conmed Corporation
ConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6047-431. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.
| Date | Oct 27, 2006 (initiated Oct 12, 2006) |
| Status | Terminated |
| Reason | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. |
| Root cause | Nonconforming Material/Component |
| Action | On 10/12/06, ConMed sent "URGENT DEVICE RECALL" packages (letter dated 10/11/06) to the domestic accounts via UPS Ground, and via UPS Express for the International accounts. Devices are to be removed from use and returned. |
| Quantity | 32 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943327 | CONMED SELECTONE MINIMAL ACCESS SURGERY INSTRUMENTS Conmedcorp, Nov 7, 1994 |