Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE… recallZ-0463-2012 · Smith & Nephew, Inc. Endoscopy Division · initiated Nov 7, 2011
Terminated All recalls posted in January 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smith & Nephew, Inc. Endoscopy Division or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0463-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 7, 2011
- Posted by the FDA
- Jan 11, 2012
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Quantity
- 1743 units
- Product code
- GEI
- FDA submissions
- K012314
- Distribution
- Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Dubai, Finland, France, Germany, Norway, South Africa, Switzerland, United Kingdom, and Venezuela.
Product description
Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector Catalog Number: 7205962.
Code information (models, lots, serial numbers)
Lot Numbers: 830567, 830568, 830569, 863004, 868509, 868519, 875226, 875227, and 897191.
Other devices under the same FDA submission
2 devices cleared under K012314 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 7209855Smith & Nephew, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES3 reports
- NA 7209700Smith & Nephew, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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