BEUDAMED
    FDA Enforcement Class II Terminated

    6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.

    Recall: Z-0139-2013 · Reported October 31, 2012

    Enforcement

    Recall Number
    Z-0139-2013
    Event ID
    63321
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Encore Medical, Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 31, 2012
    Initiation Date
    September 28, 2012
    Classification Date
    October 25, 2012
    Termination Date
    January 25, 2013
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758, United States

    Description

    6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.

    Reason

    A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws labeled as size 25, but a size 30 screw was inside of the package. It was thought that all of these screws were found in-house and were contained, but it was determined later that on

    Code Info

    Model Number 10-55-025, Lot Number 006A1057.

    Distribution

    Nationwide Distribution only to CA.

    Quantity

    1 unit