BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-1514-06 · Initiated May 22, 2006

    Recall

    Recall Number
    Z-1514-06
    Event Number
    35557
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    FEI Number
    3003604053
    Product Code
    JEB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 22, 2006
    Posted
    September 30, 2006
    Terminated
    May 9, 2012
    Address
    150 Minuteman Drive, Andover, MA, 01810-1031

    Description

    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

    Reason

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

    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.

    Distribution

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

    Quantity

    3