BEUDAMED
    FDA Recall Terminated

    Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.

    Recall: Z-1066-2013 · Initiated January 24, 2013

    Recall

    Recall Number
    Z-1066-2013
    Event Number
    64505
    Firm
    Stelkast Co
    FEI Number
    3004142400
    Product Code
    OQG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 24, 2013
    Posted
    April 7, 2013
    Terminated
    October 8, 2014
    Address
    200 Hidden Valley Rd, Mcmurray, PA, 15317-2659

    Description

    Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.

    Reason

    Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell.

    Action

    The firm initiated their recall of this product on January 24, 2013 by notifying their consignees by telephone informing them of the recall.

    Distribution

    Nationwide Distribution including the states of NV, OK and PA.

    Quantity

    254