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U.S. Department of Health and Human Services

Class 3 Device Recall Smith & Nephew, Well Leg Holder

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 Class 3 Recall
Smith & Nephew, Well Leg Holder
see related information
Date Posted June 06, 2007
Recall Status1 Terminated on June 16, 2008
Recall Number Z-0872-2007
Recall Event ID 37792
Product Classification Accessories,Arthroscopic - Product Code NBH
Product Well Leg Holder With Boot, part of the Supine Universal Hip Distractor System; Ref (Part) #72200632; Manufactured for Smith & Nephew, Inc., Endoscopy Divsion, Andover, MA 01810.
Code Information Serial #s: 286092, 287285, 287287, 287288, 287289, 287290, 287291, 289740, 289743, 290456, 290457 and 290837.
Recalling Firm/
Manufacturer
Smith & Nephew, Inc Endoscopy Division
76 S. Meridian Ave
Oklahoma City, Oklahoma 73107-6512
Manufacturer Reason
for Recall
The device was not manufactured to correct specification causing interference when used in conjunction with Patient Transfer Board.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Firm notified consignees by letter and phone call on 11/1/2006. Consignees asked to return out-of-spec Well Leg Holder for a replacement.
Quantity in Commerce 12
Distribution Nationwide Distribution: USA including states of WI, CA, MO, IL, TX, MA, WA, NM, FL, NH, and SC and the UK
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.
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