BEUDAMED
    FDA Enforcement Class II Terminated

    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.

    Recall: Z-0045-2017 · Reported October 12, 2016

    Enforcement

    Recall Number
    Z-0045-2017
    Event ID
    75068
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LDR Spine USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 12, 2016
    Initiation Date
    August 29, 2016
    Classification Date
    October 5, 2016
    Termination Date
    January 13, 2017
    Address
    13785 Research Blvd Ste 200, N/A, Austin, TX, 78750-1895, United States

    Description

    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.

    Reason

    The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of the rotation of the t-handle. There have been no reports of patient injury

    Code Info

    Lot # 2295101A, 2295101A-R, 2296101A-R

    Distribution

    US Distribution to states of: GA, OR, FL, KY, NC, AR and PA.

    Quantity

    24 units