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U.S. Department of Health and Human Services

Class 3 Device Recall TRIVEX

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  Class 3 Device Recall TRIVEX see related information
Date Initiated by Firm October 12, 2004
Date Posted August 02, 2007
Recall Status1 Terminated 3 on August 02, 2007
Recall Number Z-1105-2007
Recall Event ID 37614
510(K)Number K032387  
Product Classification Pneumatic Footswitch - Product Code DWQ
Product Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andover, MA 01810.
Code Information Pnuematic Footswitch part of TRIVEX System with the following serial numbers: 105, 106, 108, 109, 111 -123, 125 - 182, 184 - 188, 192 - 197, 199 - 203, 205 - 219, 222 - 249, 252 - 254, and 7210386.
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc Endoscopy Division
76 S. Meridian Ave
Oklahoma City OK 73107-6512
Manufacturer Reason
for Recall		 Build-up of static charge in Pneumatic Footswitch tubing may cause control unit to reset to default settings in the operating room during surgery.
FDA Determined
Cause 2		 Other
Action Firm sent notification letters to consignees via overnight FedEx on 10/12-13/04. International customers were notified via letter on 11/10/04. Customers were asked to return footswitches for a replacement.
Quantity in Commerce 274 units.
Distribution Product sent to distributors nationwide and to the following countries: Australia, Austria, Canada, China, Germany, Italy, Japan, and Taiwan.
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 = DWQ and Original Applicant = SMITH & NEPHEW, INC.
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