BEUDAMED
    FDA Enforcement Class II Terminated

    CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208

    Recall: Z-0954-2023 · Reported January 18, 2023

    Enforcement

    Recall Number
    Z-0954-2023
    Event ID
    91109
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CoreLink LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    January 18, 2023
    Initiation Date
    October 20, 2022
    Classification Date
    January 12, 2023
    Termination Date
    August 20, 2024
    Address
    2072 Fenton Logistics Park, Fenton, MO, 63026-2504, United States

    Description

    CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208

    Reason

    Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.

    Code Info

    UDI/DI M725AT32080, Lot Codes: SM135217, SM129260

    Distribution

    US Nationwide distribution.

    Quantity

    18 units