BEUDAMED
    FDA Enforcement Class II Ongoing

    CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only

    Recall: Z-2537-2025 · Reported September 17, 2025

    Enforcement

    Recall Number
    Z-2537-2025
    Event ID
    97281
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CORNEAT VISION, LTD.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 17, 2025
    Initiation Date
    October 16, 2024
    Classification Date
    September 5, 2025
    Address
    4, Ha-Sheizaf, N/A, Ra'Anana, N/A, N/A, Israel

    Description

    CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only

    Reason

    Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.

    Code Info

    UDI-DI: G16010362950

    Distribution

    Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Argentina, Israel, Hong Kong.

    Quantity

    N/A