BEUDAMED
    FDA Recall Terminated

    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 46 mm cup Ref.: 74120146

    Recall: Z-0862-2007 · Initiated March 13, 2007

    Recall

    Recall Number
    Z-0862-2007
    Event Number
    37782
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 13, 2007
    Posted
    June 7, 2007
    Terminated
    October 28, 2011
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 46 mm cup Ref.: 74120146

    Reason

    The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.

    Action

    The consignees (hospital CEOs) were notified of the problem and the recall by letter (Fed Ex) on 03/13/2007.

    Distribution

    Europe. No domestic distribution.

    Quantity

    1 unit