BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R

    Recall: Z-0352-2018 · Reported January 24, 2018

    Enforcement

    Recall Number
    Z-0352-2018
    Event ID
    78790
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Sofamor Danek USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 24, 2018
    Initiation Date
    December 6, 2017
    Classification Date
    January 14, 2018
    Termination Date
    November 4, 2019
    Address
    1800 Pyramid Pl, N/A, Memphis, TN, 38132-1703, United States

    Description

    Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R

    Reason

    Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.

    Code Info

    UDI 00643169097254 Lot Numbers: WI424428, WI428822, WI435227, WI439940, WI442555, WI446722, WI449819, WI455595, WI459477, WI463434, WI472175, WI472178, WI472176, WI472177, WI474575

    Distribution

    US. Austria, Belgium, Bulgaria, Canada, France, Germany, Italy, Lebanon, Luxembourg, Portugal, South Africa, US

    Quantity

    3,319 units