Class 2 Device Recall Smith & Nephew

• Date Initiated by Firm: May 22, 2006
• Date Posted: September 30, 2006
• Recall Status: Terminated on May 09, 2012
• Recall Number: Z-1514-06
• Recall Event ID: 35557
• Product Classification: Hip Positioning system - Product Code JEB
• Product: Smith & Nephew Hip Positioning System Ref: 72200624 with System Components: Perineal Post 72200631 Universal Hip Distractor 72200626 Knee Holder 72200627 Well Leg Holder 72200632 Supine Table Extension 72200629
• Code Information: Product distributed prior to May 5, 2006
• FEI Number: 3003604053
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc. Endoscopy Division; 150 Minuteman Drive; Andover MA 01810-1031
• For Additional Information Contact: Jason Bilobram; 978-474-6332
• Manufacturer Reason for Recall: The Perineal Post may crack or break and the Universal Hip Distractor (carriage) may not maintain adequate traction for the duration of the procedure
• FDA Determined Cause: Other
• Action: Smith & Nephew notified accounts on 5/22/06 by Letter via Federal Express to User Facility and Sales Reps and follow up telephone call to the user facilities. Devices are requested to be returned.
• Quantity in Commerce: 3
• Distribution: Nationwide distribution ---- including states of NM, MO, and TN.
• 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.