BEUDAMED
    FDA Enforcement Class II Terminated

    Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010

    Recall: Z-1156-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1156-2020
    Event ID
    84770
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medicrea International
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 19, 2020
    Initiation Date
    October 2, 2019
    Classification Date
    February 12, 2020
    Termination Date
    February 8, 2021
    Address
    5389 Route De Strasbourg, Vancia, Rillieux La Pape, N/A, France

    Description

    Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010

    Reason

    Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter

    Code Info

    Lot Numbers l9B0570; 19B0572

    Distribution

    OH, VA

    Quantity

    14 units