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.
- Company
- Conmed Corporation
- Recall Initiated
- June 17, 2015
- Posted
- November 3, 2015
- Terminated
- April 11, 2017
- Recall Number
- Z-0205-2016
- Quantity
- 276 devices
- Firm Location
- Utica, NY
Reason for Recall
Probe programming error. The incorrect program can generate more heat at the surgical site, resulting in an elevated probability of tissue damage.
Distribution
Worldwide - US distribution in the states of FL, OH, and the country of Spain.
Lot / Code Info
1412161, 1410201, 1410271, 1412121, and 1412081
Root Cause
Software design (manufacturing process)
Action Taken
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 can call Gregory Connell at 727-399-5276 or email AES50S@conmed.com. Customers should also complete and return the Recall Reply Form by mail to the address listed on the recall notice.