BEUDAMED
    FDA Recall Open, Classified

    HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

    Recall: Z-1573-2022 · Initiated July 29, 2021

    Recall

    Recall Number
    Z-1573-2022
    Event Number
    90603
    Firm
    Mizuho OSI
    FEI Number
    2921578
    Product Code
    LXH
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    July 29, 2021
    Address
    30031 Ahern Ave, Union City, CA, 94587-1234

    Description

    HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

    Reason

    One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.

    Action

    On or about 07/05/2022, Muzuho OSI Representative started visiting customers to inform them of a labeling error with the Femur Hook, Right 6850-918 which was incorrectly label with part number 6850-144. Mizuho Representatives were instructed to inform customers: -Over this summer, their facility should have received a Classic Femur Hook, Right 6850-144, either as part of your Hana Table purchase or as a replacement part. But, in error, may have received the other style of femur hook mislabeled with the part number 6850-144. -Hand deliver the Customer Notification Letter and Acknowledge Form. Mizuho Representative are further instructed to: -Inspect the customers' inventory and swap/replace all incorrectly labeled products with the correctly labeled product.

    Distribution

    U.S Nationwide Distribution .: CA, FL, GA, MI, NE, NJ, TN, UT, and WA O.U.S.: Canada

    Quantity

    13 devices