Recall Z-0089-2007 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Conmed Corporation
ConMed DetachaTip Laparoscopic Instrument: Endoweave Multiple Use Grasper, 5mm x 43cm length, REF/Product Code 1-4328. --- 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 | 106 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924283 | MICROSURGE DETACHA-TIP SURGICAL INSTRUMENTS Microsurge, Inc., Apr 7, 1993 |