BEUDAMED
    FDA Enforcement Class II Ongoing

    IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar

    Recall: Z-2453-2023 · Reported August 30, 2023

    Enforcement

    Recall Number
    Z-2453-2023
    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, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; 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

    a) B15111209, GTIN 03613720193395, Lot Numbers: 19C0772; b) B15111212, GTIN 03613720193401, Lot Numbers: 19C0775, 19G0070; c) B15111409, GTIN 03613720193425, Lot Numbers: 19E0353; d) B15111412, GTIN 03613720193432, Lot Numbers: 19C0788

    Distribution

    US nationwide

    Quantity

    11 units