BEUDAMED
    FDA Recall Terminated

    Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC1439

    Recall: Z-0664-2009 · Initiated October 7, 2008

    Recall

    Recall Number
    Z-0664-2009
    Event Number
    50128
    Firm
    Stelkast Co
    FEI Number
    3004142400
    Product Code
    LWJ
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    October 7, 2008
    Posted
    January 28, 2009
    Terminated
    April 1, 2009
    Address
    200 Hidden Valley Rd, Mcmurray, PA, 15317-2659

    Description

    Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC1439

    Reason

    Sterility may be compromised due to breach in packaging.

    Action

    On 10/7/08, Stelkast telephoned the two customers of the problem and the need to return the products.

    Distribution

    USA distribution to dealers in TX and WV.

    Quantity

    6 units