BEUDAMED
    FDA Enforcement Class II Terminated

    Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.

    Recall: Z-0849-2018 · Reported March 14, 2018

    Enforcement

    Recall Number
    Z-0849-2018
    Event ID
    79072
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 14, 2018
    Initiation Date
    July 26, 2017
    Classification Date
    March 2, 2018
    Termination Date
    April 3, 2019
    Address
    325 Paramount Dr, N/A, Raynham, MA, 02767-5199, United States

    Description

    Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.

    Reason

    Potential for Intra-operative breakage of driver tips

    Code Info

    Product code: 287804102 Lot number: 122315-B R, 122315-A R, 041117A

    Distribution

    Nationwide Distribution

    Quantity

    130 units total