BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2516-2025 · Initiated July 16, 2025

    Recall

    Recall Number
    Z-2516-2025
    Event Number
    97367
    Firm
    PREMIA SPINE LTD Giborey Israel 7 Ramat Poleg Netanya Israel
    FEI Number
    3012401682
    Product Code
    QWK
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    July 16, 2025
    Posted
    September 4, 2025

    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.

    Action

    On 07/16/2025, Premia Spine Ltd. notified Premia Spine Inc. via phone call. It was requested to quarantine any suspected reworked instruments that are at the warehouse and to initiate a field action and return the affected units of the TOPS Inserter that underwent rework. No customers (hospitals/physicians) were asked to quarantine or return units as all affected units were within Premia Spine's control, however one surgeon was notified, on about 07/31/2025, of the issue and was requested to review the surgical procedure, analyze relevant patient data, including x-ray, and perform additional actions if needed to confirm the pin has not remained in the patient's body.

    Distribution

    US Nationwide distribution in the state of Connecticut.

    Quantity

    30 units