BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1156-2020 · Initiated October 2, 2019

    Recall

    Recall Number
    Z-1156-2020
    Event Number
    84770
    FEI Number
    1000432246
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 2, 2019
    Terminated
    February 8, 2021
    Address
    Medicrea International 5389 Route De Strasbourg Vancia Rillieux La Pape 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

    Action

    Medicrea Issued Voluntary Product Recall dated 10/3/19 stating reason for recall, health risk and action to take: 1. Immediately check your internal inventory and quarantine all subject devices pending return to MEDICREA USA 2. Circulate this notification internally to all interested/affected parties. 3. Inform MEDICREA USA if any of the subject devices have been distributed to other organizations. 4. Please inform M EDICREA of any adverse events concerning the use of the subject devices. Complete the attached customer response form. Contact person for this action is given below: Tim Huntington MEDICREA USA QA Manager Tel : 646-490-2426 Mail : [email protected]

    Distribution

    OH, VA

    Quantity

    14 units