BEUDAMED
    FDA Enforcement Class II Terminated

    8mm FlexDex Needle Driver, Product Code FD-335 ND

    Recall: Z-0531-2022 · Reported February 2, 2022

    Enforcement

    Recall Number
    Z-0531-2022
    Event ID
    89316
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    FlexDex Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 2, 2022
    Initiation Date
    December 22, 2021
    Classification Date
    January 27, 2022
    Termination Date
    July 25, 2023
    Address
    10421 Citation Dr Ste 900, Brighton, MI, 48116-6558, United States

    Description

    8mm FlexDex Needle Driver, Product Code FD-335 ND

    Reason

    The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used.

    Code Info

    All lots

    Quantity

    273