BEUDAMED
    FDA Enforcement Class II Terminated

    CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use.

    Recall: Z-1494-2015 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1494-2015
    Event ID
    70859
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Wright Medical Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2015
    Initiation Date
    March 6, 2015
    Classification Date
    April 22, 2015
    Termination Date
    August 5, 2018
    Address
    1023 Cherry Rd, Memphis, TN, 38117-5423, United States

    Description

    CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use.

    Reason

    The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction

    Code Info

    Lot Numbers: 3504927, 35049-27A, 35049-27A-1, 35049-28, 362801, 36280-1-1, 8752-010381

    Distribution

    Nationwide Distribution.

    Quantity

    233 units