BEUDAMED
    FDA Enforcement Class II Terminated

    KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.

    Recall: Z-1057-2015 · Reported February 11, 2015

    Enforcement

    Recall Number
    Z-1057-2015
    Event ID
    70414
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Sofamor Danek USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 11, 2015
    Initiation Date
    January 13, 2015
    Classification Date
    February 5, 2015
    Termination Date
    July 13, 2015
    Address
    1800 Pyramid Place, N/A, Memphis, TN, 38132, United States

    Description

    KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.

    Reason

    The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments.

    Code Info

    WI14H054

    Distribution

    Nationwide and Canada

    Quantity

    239 units