BEUDAMED
    FDA Enforcement Class II Ongoing

    IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical

    Recall: Z-2461-2023 · Reported August 30, 2023

    Enforcement

    Recall Number
    Z-2461-2023
    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 S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical

    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) B15328071S, GTIN 03613720195535, Lot Numbers: 19I0696, 20A0759; b) B15328073S, GTIN 03613720195573, Lot Numbers: 20B0747; c) B15328074S, GTIN 03613720195597, Lot Numbers: 19I0698; d) B15334072S, GTIN 03613720195832, Lot Numbers: 19I0557, 20F0185; e) B15334073S, GTIN 03613720195856, Lot Numbers: 19J0947; f) B15334074S, GTIN 03613720195870, Lot Numbers: 19E0502, 19J0091, 20F0184

    Distribution

    US nationwide

    Quantity

    0 (US)