BEUDAMED
    FDA Enforcement Class II Ongoing

    Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System.

    Recall: Z-2257-2024 · Reported July 10, 2024

    Enforcement

    Recall Number
    Z-2257-2024
    Event ID
    94682
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Nalu Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 10, 2024
    Initiation Date
    June 3, 2024
    Classification Date
    July 3, 2024
    Address
    2320 Faraday Ave Ste 100, N/A, Carlsbad, CA, 92008-7216, United States

    Description

    Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System.

    Reason

    Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be non-functional, which causes the device to be non-functional so it will no longer inhibit the transmission of pain signals to the brain.

    Code Info

    UDI-DI: 71005-US: 00812537036137, 00812537033600, 00812537033518, 00812537030975, 00812537030524. 71019-US: 00812537036441, 00812537035604, 00812537035598 Serial Numbers: H01377, H01382, H01432, H01419, H01387, H01445, H01415, H01441, H01373, H01428, H01378, H01438, H01431

    Distribution

    US Nationwide distribution in the states of MO, IL, CA, TX, TN, OK, AZ, AR.

    Quantity

    13