Recall Z-0205-2016 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ConMed Corporation
Arthroscopic Energy 50 Probe with Suction, Catalog number: AES-50S Peoduct Usage: For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures.
| Date | Nov 3, 2015 (initiated Jun 17, 2015) |
| Status | Terminated |
| Reason | Probe programming error. The incorrect program can generate more heat at the surgical site, resulting in an elevated probability of tissue damage. |
| Root cause | Software design (manufacturing process) |
| Action | On June 17, 2015 Con Med Corporation distributed Urgent Device Recall Notification Letters and Recall Reply forms to their customers via courier service. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine their inventory for any of the affected lot numbers referenced on the recall notice. If any of the recalled product are in stock, customers should discontinue the use or distribution of these items. If product was further distributed, customers should notify those individuals of this recall action. Customers with questions ca |
| Quantity | 276 devices |
| Distribution | Worldwide - US distribution in the states of FL, OH, and the country of Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140578 | ARTHROSCOPIC ENERGY SYSTEM Conmed Corporation, Jul 23, 2014 |