BEUDAMED
    FDA Enforcement Class II Terminated

    Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068

    Recall: Z-0104-2022 · Reported October 20, 2021

    Enforcement

    Recall Number
    Z-0104-2022
    Event ID
    88630
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    K2M, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 20, 2021
    Initiation Date
    September 8, 2021
    Classification Date
    October 13, 2021
    Termination Date
    May 17, 2024
    Address
    600 Hope Pkwy SE, N/A, Leesburg, VA, 20175-4428, United States

    Description

    Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068

    Reason

    Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.

    Code Info

    Lots CCUNA, HYMJ, KNCU

    Distribution

    Domestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign distribution to Columbia, UK, Netherlands, and Canada.

    Quantity

    23