BEUDAMED
    FDA Enforcement Class II Terminated

    Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033

    Recall: Z-1410-2021 · Reported April 21, 2021

    Enforcement

    Recall Number
    Z-1410-2021
    Event ID
    87565
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    K2M, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 21, 2021
    Initiation Date
    March 16, 2021
    Classification Date
    April 12, 2021
    Termination Date
    August 12, 2021
    Address
    600 Hope Pkwy SE, N/A, Leesburg, VA, 20175-4428, United States

    Description

    Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033

    Reason

    Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and splaying of the collet. If implant falls into the spinal cord may cause a spinal cord injury or Incomplete seating of the inserter to the implant could result in misalignment of the screws with the inserter screw guide, potentially causing malposition of the screws into the adjacent vertebral bodies

    Code Info

    Lot Number: MNAJ GTIN: 10888857082571

    Distribution

    PA

    Quantity

    1 unit