BEUDAMED
    FDA Enforcement Class II Ongoing

    Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.

    Recall: Z-0832-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0832-2025
    Event ID
    95961
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cook Biotech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 22, 2025
    Initiation Date
    November 22, 2024
    Classification Date
    January 10, 2025
    Address
    1425 Innovation Pl, W Lafayette, IN, 47906-1000, United States

    Description

    Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.

    Reason

    Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

    Code Info

    Lot #LB1576761, exp. 1/21/2025; and Lot #LB1577308, exp. 1/21/2025; Box UDI-DI 10827002602851, Pouch UDI-DI 00827002602854.

    Distribution

    US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.

    Quantity

    49 devices