BEUDAMED
    FDA Enforcement Class II Terminated

    Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: Clinical Innovations, LLC* * *Reorder Number: UM750* * *LOT 181183* * *." Each device is accompanied by Instruction for Use which is similarly labeled.

    Recall: Z-2118-2020 · Reported June 3, 2020

    Enforcement

    Recall Number
    Z-2118-2020
    Event ID
    85144
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Clinical Innovations, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 3, 2020
    Initiation Date
    May 30, 2019
    Classification Date
    May 26, 2020
    Termination Date
    August 24, 2020
    Address
    747 W 4170 S, N/A, Murray, UT, 84123-1364, United States

    Description

    Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: Clinical Innovations, LLC* * *Reorder Number: UM750* * *LOT 181183* * *." Each device is accompanied by Instruction for Use which is similarly labeled.

    Reason

    An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result in a delay in surgery and additional surgical interventions to completed the procedure. There was a report of an injury.

    Code Info

    Model Number: UM750 Lot Number: 181183

    Distribution

    International distribution to the country Japan.

    Quantity

    280 devices