Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector Catalog Number: 7205962.
FDA Recall Z-0463-2012 · Posted 2012-01-11
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Recalling FirmSmith & Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeGEI
Date Initiated2011-11-07
Date Terminated2016-02-22
Product Quantity1743 units
Reason for Recall
Manufacturing issue: The distal tip of the outer sheath (return electrode) may detach and become loose in the joint during use.
Firm Action
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 [email protected] for information on how to return the affected product and receive replacement product. Questions, contact Hoangthi Le directly by phone at 508-337-3731.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Dubai, Finland, France, Germany, Norway, South Africa, Switzerland, United Kingdom, and Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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