BEUDAMED
    FDA Enforcement Class II Ongoing

    TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.

    Recall: Z-2516-2025 · Reported September 10, 2025

    Enforcement

    Recall Number
    Z-2516-2025
    Event ID
    97367
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    PREMIA SPINE LTD
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 10, 2025
    Initiation Date
    July 16, 2025
    Classification Date
    September 4, 2025
    Address
    Giborey Israel 7, Ramat Poleg, Netanya, N/A, N/A, Israel

    Description

    TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.

    Reason

    Potential for missing pins at tip of inserter.

    Code Info

    Model Number: 82889. UDI-DI: 07290115932638. Lot Numbers: RS20220546-1, RS20222162-1, RS20171777-1, RS20171884-1, RS0431-13B-1, 20152764-1, RS0431-02-1.

    Distribution

    US Nationwide distribution in the state of Connecticut.

    Quantity

    30 units