Recall Z-0008-2013 ยท HGI Electrocautery, Gynecologic (And Accessories)
Gynex Corporation
Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the electrode to the food activated electric generator. Electrodes are used in gynecolo
| Date | Oct 3, 2012 (initiated Sep 6, 2012) |
| Status | Terminated |
| Reason | The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. this electrical connector is too big to fit into the port on the foot activated generator. this makes the device unusable. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were first notified by phone with a follow up e-mail or fax. The consignees were asked to complete the response section regarding the destruction/return of the device. For questions regarding this recall call 425-882-1179. |
| Quantity | 19 boxes (containing 12 electorde hand pieces each) |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.