BEUDAMED
    FDA Enforcement Class II Terminated

    CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE Orthopedic

    Recall: Z-2602-2014 · Reported September 17, 2014

    Enforcement

    Recall Number
    Z-2602-2014
    Event ID
    69058
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Wright Medical Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 17, 2014
    Initiation Date
    July 30, 2014
    Classification Date
    September 8, 2014
    Termination Date
    June 15, 2018
    Address
    1023 Cherry Rd, N/A, Memphis, TN, 38117-5423, United States

    Description

    CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE Orthopedic

    Reason

    Plates manufactured from an incorrect raw material.

    Code Info

    Lot Numbers: 1490004, 1490005, 1490199, 1490200, 1490201, 1490202, 1518483, 1519493, 1519494, 1519495, 1522021, 1522898, 1522899, 1522900, 1523735, 1523736, 1526519, 1526520, 1526521, 1538760, 1538761, 1539402, 1540715, 1540716, 1540717, 1542703, 1542704, 1542776, 1543491, 1543891

    Distribution

    Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.

    Quantity

    1127 units