Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector Catalog Number: 7205962.
This recall has been terminated (originally issued January 11, 2012).
- Recall Initiated
- November 7, 2011
- Posted
- January 11, 2012
- Terminated
- February 22, 2016
- Recall Number
- Z-0463-2012
- Quantity
- 1743 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Manufacturing issue: The distal tip of the outer sheath (return electrode) may detach and become loose in the joint during use.
Distribution
Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Dubai, Finland, France, Germany, Norway, South Africa, Switzerland, United Kingdom, and Venezuela.
Lot / Code Info
Lot Numbers: 830567, 830568, 830569, 863004, 868509, 868519, 875226, 875227, and 897191.
Root Cause
Process control
Action Taken
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.