Recall Z-0103-2007 ยท GCJ Laparoscope, General & Plastic Surgery
Conmed Corporation
ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-004. --- 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 company was made aware of instances where the grasper jaws broke during laparoscopic procedures. When the grasper jaws had broken they had done so at the junction of the jaw and the tube. In no instances was it reported to the company that small pieces had broken off of the grasper jaws. |
| 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 | 38 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 |