Class 3 Device Recall Smith & Nephew, Well Leg Holder

• Date Initiated by Firm: November 01, 2006
• Date Posted: June 06, 2007
• Recall Status: Terminated on June 16, 2008
• Recall Number: Z-0872-2007
• Recall Event ID: 37792
• Product Classification: Well Leg Holder (Arthroscopic Accessory) - 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 OK 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: Other
• 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 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.