BEUDAMED
    FDA Enforcement Class II Ongoing

    OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.

    Recall: Z-0955-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0955-2025
    Event ID
    95981
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    IsoTis OrthoBiologics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 22, 2025
    Initiation Date
    November 27, 2024
    Classification Date
    January 16, 2025
    Address
    2 Goodyear Ste A, Irvine, CA, 92618-2052, United States

    Description

    OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.

    Reason

    Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.

    Code Info

    UDI-DI: 10889981055820, Lot 1031907, Exp. 2025-11-28 (Inner Tray Exp. 2024-11-28) and Lot 1031825, Exp. 2025-07-28 (Inner tray Exp. 2025-03-28)

    Distribution

    US Nationwide distribution in the states of IN, TN & TX.

    Quantity

    22