BEUDAMED
    FDA Enforcement Class II Ongoing

    Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant

    Recall: Z-2117-2023 · Reported July 19, 2023

    Enforcement

    Recall Number
    Z-2117-2023
    Event ID
    92567
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Sofamor Danek USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 19, 2023
    Initiation Date
    June 6, 2023
    Classification Date
    July 10, 2023
    Address
    1800 Pyramid Pl, N/A, Memphis, TN, 38132-1703, United States

    Description

    Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant

    Reason

    There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

    Code Info

    UDI/DI 00763000465865, Lot Numbers: NM21J001, NM21J014

    Distribution

    US Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX, NC, OR, NE, MN, FL.

    Quantity

    34 units