BEUDAMED
    FDA Enforcement Class II Terminated

    Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT screw by rocking the instrument back and forth until the entire tab is fully detached from the screw head. Catalog number: 5101-90195

    Recall: Z-0542-2021 · Reported December 16, 2020

    Enforcement

    Recall Number
    Z-0542-2021
    Event ID
    86733
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    K2M, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 16, 2020
    Initiation Date
    November 4, 2020
    Classification Date
    December 7, 2020
    Termination Date
    February 22, 2024
    Address
    600 Hope Pkwy SE, N/A, Leesburg, VA, 20175-4428, United States

    Description

    Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT screw by rocking the instrument back and forth until the entire tab is fully detached from the screw head. Catalog number: 5101-90195

    Reason

    All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between tool s metal shaft component and handle, resulting in leakage of Loctite from handle cracks

    Code Info

    Lot Numbers: JUFT, JUGX, KEFE, KUBJ, KVNT, KYRR, MAJR GTIN: 10888857290679

    Distribution

    Nationwide Foreign: Netherlands, Spain, UK, Belgium, Germany, Italy, Norway and Sweden

    Quantity

    197 units