—#46391

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

FDA product code: JEB — Table, Surgical With Orthopedic Accessories, Manual
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Product distributed prior to May 5, 2006

Why it was recalled

The Perineal Post may crack or break and the Universal Hip Distractor (carriage) may not maintain adequate traction for the duration of the procedure

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc. Endoscopy Division
Address: 150 Minuteman Drive, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern: Nationwide distribution ---- including states of NM, MO, and TN.

Timeline

Recall initiated: 2006-05-22
Posted by FDA: 2006-09-30
Terminated: 2012-05-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #46391. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.