BEUDAMED
    FDA Enforcement Class II Terminated

    djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair

    Recall: Z-2146-2012 · Reported August 15, 2012

    Enforcement

    Recall Number
    Z-2146-2012
    Event ID
    62561
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Encore Medical, Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2012
    Initiation Date
    July 16, 2012
    Classification Date
    August 6, 2012
    Termination Date
    December 4, 2012
    Address
    9800 Metric Blvd, Austin, TX, 78758, United States

    Description

    djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair

    Reason

    One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm.

    Code Info

    Lot 007A1037, Ref 010-55-25.

    Distribution

    Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.

    Quantity

    18 devices