Recall Z-1413-04 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Conmed Corporation
ConMed Stealth Coated Laparoscopic Electrodes with 4mm pin (60-5158 series) as follows: Cat. #60-5158-034 - Spatula, 5 mm x 32 cm; Cat #60-5158-432 - ''L'' Hook 5 mm x 32 cm; Cat #60-5158-934 - Needle 5mm x 32 cm; Firm on label: ConMed Corporation, Utica, New York 13502.
| Date | Aug 28, 2004 (initiated Aug 9, 2004) |
| Status | Terminated |
| Reason | Insulation may pull away from the hub of the electrode exposing the conductive shaft below. This condition results in potential for electrical shock. |
| Root cause | Other |
| Action | Letters dated 8/9/04 via Priority Mail with instructions to return product and subrecall if further distributed. |
| Quantity | 1,005 units |
| Distribution | There are 127 distributors, hospitals and sales representatives in the U.S. There are 21 foreign consignees in Australia, Brazil, Canada, Costa Rica, Ecuador, Finland, India, Israel, Italy, Norway, Peru, Saudi Arabia, Spain, Turkey, United Kingdom, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960808 | CONMED SELECT ONE LAPAROSCOPY ELECTRODE Conmedcorp, Mar 21, 1996 |