BEUDAMED
    FDA Recall 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 · Initiated January 13, 2015

    Recall

    Recall Number
    Z-1057-2015
    Event Number
    70414
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    LYQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 13, 2015
    Posted
    February 5, 2015
    Terminated
    July 13, 2015
    Address
    1800 Pyramid Place, Memphis, TN, 38132

    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.

    Action

    On January 12, 2015, the Sales Managers and Sales Force were notified by Post-Market Quality regarding the imminent notification and follow-up activities. The recall notices were delivered to the Risk Managers at impacted consignee sites on January 13, 2015. These recall notices included a Risk Manager Letter informing them on the action, and a consignee-specific questionnaire to indicate their product on-hand.

    Distribution

    Nationwide and Canada

    Quantity

    239 units