BEUDAMED
    FDA Recall 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 · Initiated May 10, 2017

    Recall

    Recall Number
    Z-2318-2017
    Event Number
    77251
    Firm
    Zimmer Biomet Spine Inc.
    FEI Number
    3012447612
    Product Code
    LYQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 10, 2017
    Posted
    May 15, 2017
    Terminated
    May 25, 2018
    Address
    10225 Westmoor Dr, Westminster, CO, 80021-2702

    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.

    Action

    Consignees will be notified on 5/15/17 via certified mail to return products.

    Distribution

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

    Quantity

    497 units