—#105197

Product

Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector Catalog Number: 7205962.

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K012314
Affected lot / code info: Lot Numbers: 830567, 830568, 830569, 863004, 868509, 868519, 875226, 875227, and 897191.

Why it was recalled

Manufacturing issue: The distal tip of the outer sheath (return electrode) may detach and become loose in the joint during use.

Root cause (FDA determination)

Process control

Action the firm took

Smith & Nephew Inc. Endoscopy Division notified facilities on 11/7/11 via an "Urgent - Product Recall 1st Notification - Urgent" letter and/or phone. The letter identified the affected product and the reason for the recall. It also discussed the potential risks, customer actions, and instructions for the return of the product. Customers were to check their inventory and locate any of the affected product. They were to also complete the requested contact information and return the notification letter. In addition, customers were to contact Smith & Nephew Endoscopy Division Returns Group at endo.andreturns@smith-nephew.com for information on how to return the affected product and receive replacement product. Questions, contact Hoangthi Le directly by phone at 508-337-3731.

Recalling firm

Firm: Smith & Nephew, Inc. Endoscopy Division
Address: 150 Minuteman Drive, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern: Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Dubai, Finland, France, Germany, Norway, South Africa, Switzerland, United Kingdom, and Venezuela.

Timeline

Recall initiated: 2011-11-07
Posted by FDA: 2012-01-11
Terminated: 2016-02-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105197. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.