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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew

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  Class 2 Device Recall Smith & Nephew see related information
Date Initiated by Firm May 22, 2006
Date Posted September 30, 2006
Recall Status1 Terminated 3 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
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 2		 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.
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