Recall Z-1564-2010 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ConMed Electrosurgery
ConMed Goldline Hand Controlled With Blade Electrode, Rocker Switch, Safety Holster and 10 FT Cable, REF 130307A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502.
| Date | May 10, 2010 (initiated Mar 29, 2010) |
| Status | Terminated |
| Reason | Electrosurgical pencil may remain activated or self activate after power switch is released. |
| Root cause | Device Design |
| Action | Customers were notified by letter on March 25, 2010, and were instructed to return all affected devices and to forward the recall information to anyone that may have received the devices to the end user. More information is available by contacting the firm directly at 800-552-0138. |
| Quantity | 282,000 units (US), 67,880 units (Foreign) |
| Distribution | Nationwide, including 2 VA facilities in GA and 1 military facility in UT. Foreign distribution to Australia, Belgium, Canada, China, Dominican Republic, El Salvador, Japan, Korea, Mexico, Puerto Rico, Saudi Arabia, Spain, Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K791137 | SINGLE USE MONOPOLAR HAND CONTROL PENCIL Davol, Inc., Jul 24, 1979 |