Recall Z-2282-2010 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ConMed Electrosurgery
ABC PROBE REF 160655 5 mm Footswitching Probe, QTY: 1 STERILE CONMED CORPORATION 525 French Rd, Utica, NY 13501 ASSEMBLED IN MEXICO ABC PROBE REF 160655 5 mm Footswitching Probe, QTY: 10 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with CONMED electrosurgical units equ
| Date | Aug 25, 2010 (initiated Dec 18, 2008) |
| Status | Terminated |
| Reason | The internal electrode can protrude in front of ceramic insulator at the tip of the ABC Handpiece used with Conmed Electrosurgical units. |
| Root cause | Process design |
| Action | An Urgent Device Recall notification was issued 12/18/2008, which explained the problem/risk associated with the device, the discontinuance of use and the return of the device. If you have any questions, please contact 800-552-0138, ext. 5225. |
| Quantity | Dom: 1375 cs (13750 units); Int'l: 1427 cs (14270 units) |
| Distribution | Nationwide and International |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925903 | LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION Birtcher Medical Systems, Inc., Dec 30, 1992 |