BEUDAMED
    FDA Enforcement Class II Terminated

    Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.

    Recall: Z-2684-2020 · Reported July 29, 2020

    Enforcement

    Recall Number
    Z-2684-2020
    Event ID
    85889
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NuVasive Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 29, 2020
    Initiation Date
    June 10, 2020
    Classification Date
    July 22, 2020
    Termination Date
    March 22, 2021
    Address
    7475 Lusk Blvd, N/A, San Diego, CA, 92121-5707, United States

    Description

    Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.

    Reason

    The NVM5 EMG Module kit intended for intraoperative neurophysiologic monitoring during spinal surgery contains incorrect component, part number 1715945, SSEP harness instead of the the correct part number 1747065, NVM5 Harness, Gen 3.5 EM. This issue can result in delay in therapy or lack of EMG neuromonitoring during surgery if the surgeon elects to proceed without the NVM5.

    Code Info

    Lot 1075097

    Distribution

    US Nationwide distribution including in the states of AR, CA, IA, IL, WI. OUS: None

    Quantity

    23