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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 Device Recall Smith& Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector see related information
Date Initiated by Firm November 07, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on February 22, 2016
Recall Number Z-0463-2012
Recall Event ID 60375
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 MA 01810-1031
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = SMITH & NEPHEW, INC.
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