BEUDAMED
    FDA Enforcement Class II Terminated

    DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal Construct.

    Recall: Z-0685-2013 · Reported January 23, 2013

    Enforcement

    Recall Number
    Z-0685-2013
    Event ID
    62719
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 23, 2013
    Initiation Date
    July 24, 2012
    Classification Date
    January 16, 2013
    Termination Date
    December 30, 2013
    Address
    325 Paramount Dr, N/A, Raynham, MA, 02767-5199, United States

    Description

    DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal Construct.

    Reason

    A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potentially resulting in the instrument recording torque values outside of the specification.

    Code Info

    All lots

    Distribution

    Worldwide Distribution - USA (nationwide) and internationally to Belgium, Egypt, Ireland, Italy, Portugal, and the UK.

    Quantity

    140 units