BEUDAMED
    FDA Enforcement Class II Terminated

    Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle  90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017

    Recall: Z-2318-2017 · Reported June 14, 2017

    Enforcement

    Recall Number
    Z-2318-2017
    Event ID
    77251
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet Spine Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 14, 2017
    Initiation Date
    May 10, 2017
    Classification Date
    June 8, 2017
    Termination Date
    May 25, 2018
    Address
    10225 Westmoor Dr, N/A, Westminster, CO, 80021-2702, United States

    Description

    Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle  90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017

    Reason

    Zimmer Biomet is conducting a medical device recall for Vitality T27 Final Drivers and Vitality Torque Limiting Handle  90 in-lbs because when applying torque to tighten the closure top the driver has the potential to create a torsional spring which can cause damage and the potential for the values of torque to go out of specification.

    Code Info

    Model No: 07.02066.001 (All lots); 07.02053.001 (All lots distributed prior to April 26, 2017), and 730M0017 (Lot 309622)

    Distribution

    Nationwide, military/VA/govt and foreign consignee (No Canadian consignees)

    Quantity

    497 units