BEUDAMED
    FDA Enforcement Class II Terminated

    Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw

    Recall: Z-1350-2020 · Reported March 4, 2020

    Enforcement

    Recall Number
    Z-1350-2020
    Event ID
    84638
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ulrich medical USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 4, 2020
    Initiation Date
    December 31, 2019
    Classification Date
    February 24, 2020
    Termination Date
    November 17, 2025
    Address
    18221 Edison Ave, N/A, Chesterfield, MO, 63005-3703, United States

    Description

    Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw

    Reason

    Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation.

    Code Info

    Lot Numbers: U010577, U016620, U019084

    Distribution

    AZ, TX, GA, FL, AR, CA

    Quantity

    179 units