BEUDAMED
    FDA Enforcement Class II Terminated

    CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE Orthopedic

    Recall: Z-2601-2014 · Reported September 17, 2014

    Enforcement

    Recall Number
    Z-2601-2014
    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 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE Orthopedic

    Reason

    Plates manufactured from an incorrect raw material.

    Code Info

    Lot Numbers: 1487673, 1487674, 1487675, 1487676, 1490003, 1512150, 1512151, 1519497, 1519498, 1522019, 1522020, 1523747, 1523748, 1537072, 1537073, 1537162, 1539399, 1541615, 1541616, 1543148, 1543149

    Distribution

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

    Quantity

    497 units