Z-0463-2012

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

Name: Z-0463-2012 Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector Catalog Number: 7205962
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2011-11-07
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2011-11-07 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector Catalog Number: 7205962 on 2011-11-07. The reason FDA records is "Manufacturing issue: The distal tip of the outer sheath (return electrode) may detach and become loose in the joint during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0463-2012
Status: Terminated
Initiated: 2011-11-07
Posted: 2012-01-11
Terminated: 2016-02-22
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector Catalog Number: 7205962.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Manufacturing issue: The distal tip of the outer sheath (return electrode) may detach and become loose in the joint during use.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 1743 units
Distribution: Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Dubai, Finland, France, Germany, Norway, South Africa, Switzerland, United Kingdom, and Venezuela.
Product codes and lots: Lot Numbers: 830567, 830568, 830569, 863004, 868509, 868519, 875226, 875227, and 897191.

Product code GEI

K012314Class IIDyonics Electroblade ResectorSmith & Nephew, Inc. / cleared 2002-02-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)