Recall Z-2278-2010 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ConMed Electrosurgery
ABC Bend-A-Beam Handpiece REF 134009 Handcontrol Malleable Handpiece, 9" (22.8 cm) QTY: 1 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (Pouch label) ABC Bend-A-Beam Handpiece REF 134006 Handcontrol Malleable Handpiece, 9" (22.8 cm) QTY: 10 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (Case label) Usage: Electrosurgical handpiece fo
| 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: 233 cs (2330 units); Int'l: 275 cs (2750 units) |
| Distribution | Nationwide and International |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961505 | BEND-A-BEAM HAND CONTROL MALLEABLE ABC HANDPIECE Conmedcorp, Jul 18, 1996 |