BEUDAMED
    FDA Enforcement Class II Ongoing

    KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.

    Recall: Z-1768-2025 · Reported May 21, 2025

    Enforcement

    Recall Number
    Z-1768-2025
    Event ID
    96656
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Klinika Mdical Gmb
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 21, 2025
    Initiation Date
    April 4, 2025
    Classification Date
    May 15, 2025
    Address
    Achtzehnmorgenweg 6, Usingen, N/A, Germany

    Description

    KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.

    Reason

    Potential for microbial contamination.

    Code Info

    Model Number: 2001105-F. UDI-DI: 4053185001177. Lot Number: 25.019.01

    Distribution

    US Nationwide distribution in the state of Massachusetts.

    Quantity

    620 units