Recall Z-1719-2014 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ConMed Corporation
MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
| Date | Jun 4, 2014 (initiated May 8, 2014) |
| Status | Terminated |
| Reason | ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed. |
| Root cause | Nonconforming Material/Component |
| Action | ConMed sent an Urgent Medical Device Recall letter dated May 8, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Corrective Action: All returned devices will be received into the facility and the lot number and quantity recorded on to an electronic spreadsheet. The returned product will then be stored in a secure quarantined area. At this time, management has not determined as to how the devices will be dispositioned. A protocol(s) will be written to address the destruction of the returned devices. This will |
| Quantity | Domestic - 12,600 units, Foreign - 44,280 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia, Belgium, Brazil, Canada, Ecuador, El Salvador, Finland, France, Great Britain, Honduras, India, Indonesia, Israel, Italy, Japan, Latvia, Lebanon, Malaysia, Mexico, Panama, Philippines, Portugal, Saudi Arabia, South Africa, Spa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120476 | MACROLYTE DISPERSIVE ELECTRODE Conmed Corporation, Jun 12, 2012 |