BEUDAMED
    FDA Enforcement Class III Ongoing

    NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US

    Recall: Z-1052-2023 · Reported February 15, 2023

    Enforcement

    Recall Number
    Z-1052-2023
    Event ID
    91294
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    NuVasive Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 15, 2023
    Initiation Date
    July 19, 2022
    Classification Date
    February 3, 2023
    Address
    7475 Lusk Blvd, San Diego, CA, 92121-5707, United States

    Description

    NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US

    Reason

    Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures.

    Code Info

    Part Number: 1881500 UDI Code: 0887517PLS137YJ Serial Numbers: PM00017 SM90018 SM90013 SM90021 PM00007 SM90032 SM90030

    Distribution

    U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX.

    Quantity

    7