BEUDAMED
    FDA Recall Open, Classified

    Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant

    Recall: Z-2122-2023 · Initiated June 6, 2023

    Recall

    Recall Number
    Z-2122-2023
    Event Number
    92567
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    OVD
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 6, 2023
    Posted
    July 10, 2023
    Address
    1800 Pyramid Pl, Memphis, TN, 38132-1703

    Description

    Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, 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.

    Action

    Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 06/06/2023 by UPS 2-day delivery. The notice explained the problem , risk, and requested the following actions be taken: "" For purchased inventory not consumed during a procedure: o Identify and quarantine any unused impacted product(s). Refer to the table above for impacted products. o Return the impacted product(s) to Medtronic following the instructions in the enclosed Customer Confirmation Form. " For Medtronic owned product at your facility: o Your Medtronic Sales Representative will locate and return this product. " Complete the Customer Confirmation Form enclosed with this letter (even if you have no product to return), acknowledging that you have received this information. " This notice should be distributed to all others in your organization who should be aware, or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records."

    Distribution

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

    Quantity

    8 units