BEUDAMED
    FDA Recall 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 · Initiated May 30, 2019

    Recall

    Recall Number
    Z-2118-2020
    Event Number
    85144
    Firm
    Clinical Innovations, LLC
    FEI Number
    1000220650
    Product Code
    LKF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 30, 2019
    Terminated
    August 24, 2020
    Address
    747 W 4170 S, Murray, UT, 84123-1364

    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.

    Action

    On July 2, 2019, the firm sent an field Safety Notice letter to consignees. In addition to informing consignees about the recall they asked that the following actions be taken: 1. Please provide the field safety notice to your hospitals. If you have further distributed this product, please identify your customers and notify them at once of this communication and/or contact Clinical Innovations with the contact information s that we can follow-up with the owner of the device. 2. Please quarantine any remaining product in your hospitals and completed the response card attached to this filed safety notice. A company representative will contact you and arrange for the return of the product. 3. If you have any questions, please call Clinical Innovations at 1-8880268-6222, M-F, 8:00 Am 5:00 PM MT

    Distribution

    International distribution to the country Japan.

    Quantity

    280 devices