BEUDAMED
    FDA Enforcement Class II Ongoing

    NEUROSIGN Disposable Stimulating Dissector, REF 5888-00

    Recall: Z-3131-2024 · Reported September 18, 2024

    Enforcement

    Recall Number
    Z-3131-2024
    Event ID
    95188
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Technomed Europe
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 18, 2024
    Initiation Date
    July 25, 2024
    Classification Date
    September 12, 2024
    Address
    Amerikalaan 71, Maastricht-Airport, N/A, Netherlands

    Description

    NEUROSIGN Disposable Stimulating Dissector, REF 5888-00

    Reason

    Product has have presence of brown discoloration or substance on the hinge area of the device

    Code Info

    UDI/DI 08718375869659, Lot Numbers: 061158, 061380

    Distribution

    US: FL, CA, TX, IL, NY, PA, MA

    Quantity

    71 units