BEUDAMED
    FDA Enforcement Class II 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 · Reported April 17, 2019

    Enforcement

    Recall Number
    Z-1126-2019
    Event ID
    82497
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ulrich medical USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 17, 2019
    Initiation Date
    March 8, 2019
    Classification Date
    April 11, 2019
    Termination Date
    July 10, 2020
    Address
    18221 Edison Ave, N/A, Chesterfield, MO, 63005-3703, United States

    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.

    Code Info

    Model #s CS 7130 Serial #s 538436-02_70 (69 total) UDI Description 4052536123704, Model #s CS 7134 Serial #s 538438-02_70 (69 total) UDI Description 4052536123728, Model #s CS 7146 Serial #s 04-14-022-18_23 (6 total) UDI Description4052536078301, Model #s CS 7148 Serial #s 11-12-035-01_09, 03-12-006-24, and 03-12-006-25 (11 total) UDI Description 4052536078318, and Model #s CS 8049 Serial #s J04192-31_40, J04192-056, J04192-064, H12015-031_6, and J01276-031_3, (21 total) UDI Description 4052536022076.

    Distribution

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

    Quantity

    25