BEUDAMED
    FDA Recall Terminated

    ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.

    Recall: Z-1126-2019 · Initiated March 8, 2019

    Recall

    Recall Number
    Z-1126-2019
    Event Number
    82497
    Firm
    ulrich medical USA Inc
    FEI Number
    3005532635
    Product Code
    LXL
    Status
    Terminated
    Root Cause
    Storage
    Initiated
    March 8, 2019
    Terminated
    July 10, 2020
    Address
    18221 Edison Ave, Chesterfield, MO, 63005-3703

    Description

    ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.

    Reason

    Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.

    Action

    On March 13 , 2019 the firm sent letters to their consignees stating the following: The purpose of this letter is to advise you that ulrich medical USA is voluntarily recalling certain Torque Limiting Handles. Reason for the voluntary recall: Certain Torque Limiting Handles in the field are beyond their 3 year calibration life. The calibration issue experienced to date has been limited to select instruments and not all of these instruments have been affected. Due to the nature of how these instruments are used the risk to the patient is low. No injury or death has been reported. Risk to health: Over or under tightening of the set screw could cause the construct to fatigue or loosen. The risk to the patient is low. Actions to be taken by the user: Return the torque limiting handles to ulrich medical USA at ulrichs expense, and a new torque limiting handle will be shipped back. Instructions for acknowledgement of receipt include FedEx signature required. Actions to be taken by the Company: All affected instruments will be replaced with new torque limiting handle upon return. Contact information: If you have any questions or concerns please contact: Louis Milos Sr. Manager Business and Quality Systems 18221 Edison Ave. Chesterfield, MO 63005 636-519-0268 ext. 105 [email protected] www.ulrichmedicalusa.com Available Monday through Friday 8:00am to 5:00pm CST

    Distribution

    AZ, IL, LA, MI, MO, NV, OH, PA, TN, and TX.

    Quantity

    25