—#138104

Product

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.

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K140578
Affected lot / code info: 1412161, 1410201, 1410271, 1412121, and 1412081

Why it was recalled

Probe programming error. The incorrect program can generate more heat at the surgical site, resulting in an elevated probability of tissue damage.

Root cause (FDA determination)

Software design (manufacturing process)

Action the firm took

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.

Recalling firm

Firm: ConMed Corporation
Address: 525 French Rd, Utica, New York 13502-5945

Distribution

Distribution pattern: Worldwide - US distribution in the states of FL, OH, and the country of Spain.

Timeline

Recall initiated: 2015-06-17
Posted by FDA: 2015-11-03
Terminated: 2017-04-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138104. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.