BEUDAMED
    FDA Enforcement Class II Ongoing

    OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.

    Recall: Z-0919-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0919-2025
    Event ID
    95978
    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 15, 2025
    Address
    2 Goodyear Ste A, Irvine, CA, 92618-2052, United States

    Description

    OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.

    Reason

    Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.

    Code Info

    OsteoCove Putty, REF 56920013, UDI-DI: 10889981309022, Lot Numbers: 180054, Exp. 2025-08-28; 180054R18, Exp. 2025-08-28; 179604R18, Exp. 2024-12-28; 180484, Exp. 2026-02-28; 180370, Exp. 2026-01-28; 180299, Exp. 2025-11-28; 180075, Exp. 2025-08-28; and Cove Putty, REF 02-9200-013, UDI-DI: 10889981308933, Lot Number: 180075R18, Exp. 2025-08-28.

    Distribution

    US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.

    Quantity

    145