BEUDAMED
    FDA Recall Terminated

    MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441

    Recall: Z-1410-2022 · Initiated October 25, 2021

    Recall

    Recall Number
    Z-1410-2022
    Event Number
    90544
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    HXX
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 25, 2021
    Terminated
    June 12, 2024
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441

    Reason

    Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.

    Action

    An Urgent Medical Device Removal Notification was issued October 25, 2021 sent via email and USPS certified mail. The notice identified the product MODULIFT VBR SZ.M 4MM SET SCREWDRIVER, part of Modulift VBR Medium Instrument Set, ST-0441 and requested customers identify and quarantine affected inventory, submit the acknowledgement form and contact AIS Customer Service to arrange for return of product at (866) 229-3002 and [email protected]. Distributors are to notify customers if product was further distributed.

    Distribution

    US: CA, FL, GA, IL, OH & MI

    Quantity

    9 pieces