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U.S. Department of Health and Human Services

Class 2 Device Recall Smith& Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector

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 Class 2 Recall
Smith& Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector
see related information
Date Posted January 11, 2012
Recall Status1 Open
Recall Number Z-0463-2012
Recall Event ID 60375
Premarket Notification
510(K) Number
K012314 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector Catalog Number: 7205962.
Code Information Lot Numbers: 830567, 830568, 830569, 863004, 868509, 868519, 875226, 875227, and 897191.
Recalling Firm/
Manufacturer
Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover, Massachusetts 01810-1031
Consumer Instructions Discard product or return to place of purchase for a full refund or exchange
For Additional Information Contact Catherine Chen
978-749-1341
Manufacturer Reason
for Recall
Manufacturing issue: The distal tip of the outer sheath (return electrode) may detach and become loose in the joint during use.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 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.
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = SMITH & NEPHEW, INC.
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