BEUDAMED
    FDA Enforcement Class II Ongoing

    IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar

    Recall: Z-2454-2023 · Reported August 30, 2023

    Enforcement

    Recall Number
    Z-2454-2023
    Event ID
    92738
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medicrea International
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 30, 2023
    Initiation Date
    July 12, 2023
    Classification Date
    August 24, 2023
    Address
    Vancia, Vancia, Rillieux La Pape, N/A, N/A, France

    Description

    IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar

    Reason

    There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

    Code Info

    GTIN 03613720264439, Lot Numbers: 18I0824, 19L0046

    Distribution

    US nationwide

    Quantity

    5 units