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Terminated

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 Recall Z-0205-2016 · Posted 2015-11-03

Recalling FirmConMed Corporation
Recall StatusTerminated
Product CodeGEI
Date Initiated2015-06-17
Date Terminated2017-04-11
Product Quantity276 devices

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.

Firm 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 can call Gregory Connell at 727-399-5276 or email [email protected]. Customers should also complete and return the Recall Reply Form by mail to the address listed on the recall notice.

Root Cause

Software design (manufacturing process)

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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