BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0872-2007 · Initiated November 1, 2006

    Recall

    Recall Number
    Z-0872-2007
    Event Number
    37792
    Firm
    Smith & Nephew, Inc Endoscopy Division
    FEI Number
    1643264
    Product Code
    NBH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 1, 2006
    Posted
    June 6, 2007
    Terminated
    June 16, 2008
    Address
    76 S. Meridian Ave, Oklahoma City, OK, 73107-6512

    Description

    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.

    Reason

    The device was not manufactured to correct specification causing interference when used in conjunction with Patient Transfer Board.

    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.

    Distribution

    Nationwide Distribution: USA including states of WI, CA, MO, IL, TX, MA, WA, NM, FL, NH, and SC and the UK

    Quantity

    12