BEUDAMED
    FDA Enforcement Class II Terminated

    Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.

    Recall: Z-0454-2016 · Reported December 30, 2015

    Enforcement

    Recall Number
    Z-0454-2016
    Event ID
    72654
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2015
    Initiation Date
    November 20, 2015
    Classification Date
    December 21, 2015
    Termination Date
    July 3, 2017
    Address
    325 Paramount Dr, N/A, Raynham, MA, 02767-5199, United States

    Description

    Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.

    Reason

    Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble with the tightener shaft. The design of the inspection gage does not account for the additional shift length

    Code Info

    LOT NUMBER: GB0906 GB0707 GB0907 GB58815 GB59244 GB61134

    Distribution

    US Distribution to the states of : NC, MI, CO, MD, FL, ID, TX, CA and NY.

    Quantity

    16 devices