BEUDAMED
    FDA Enforcement Class II 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 · Reported April 17, 2013

    Enforcement

    Recall Number
    Z-1066-2013
    Event ID
    64505
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stelkast Co
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 17, 2013
    Initiation Date
    January 24, 2013
    Classification Date
    April 6, 2013
    Termination Date
    October 8, 2014
    Address
    200 Hidden Valley Rd, Mcmurray, PA, 15317-2659, United States

    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.

    Code Info

    Part Numbers SC3458-52, lot number 28820-112612; SC3474-52, lot number 28822-101812; SC3459-52, lot number 28823-101812; and SC3460-52, lot number 28821-000.

    Distribution

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

    Quantity

    254