BEUDAMED
    FDA Enforcement Class II Ongoing

    IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013; intervertebral fusion device - lumbar

    Recall: Z-2455-2023 · Reported August 30, 2023

    Enforcement

    Recall Number
    Z-2455-2023
    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 DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013; 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) B16123509, GTIN 03613720196341, Lot Numbers: 20B0490; b) B16123511, GTIN 03613720196358, Lot Numbers: 19G0068; c) B16124009, GTIN 03613720196396, Lot Numbers: 19K0269; d) B16124013, GTIN 03613720196419, Lot Numbers: 19F0715; e) B16124509, GTIN 03613720196440, Lot Numbers: 19F0713; f) B16124511, GTIN 03613720196457, Lot Numbers: 19F0716; g) B16124513, GTIN 03613720196464, Lot Numbers: 19K0270; h) B16164009, GTIN 03613720196495, Lot Numbers: 18F1034; i) B16164013, GTIN 03613720196518, Lot Numbers: 18G0178; j) B16165009, GTIN 03613720196594, Lot Numbers: 18C0626; k) B16165013, GTIN 03613720196617, Lot Numbers: 18C0629;

    Distribution

    US nationwide

    Quantity

    24 units