BEUDAMED
    FDA Enforcement Class II Ongoing

    Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026

    Recall: Z-1921-2023 · Reported June 21, 2023

    Enforcement

    Recall Number
    Z-1921-2023
    Event ID
    92359
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 21, 2023
    Initiation Date
    May 3, 2023
    Classification Date
    June 14, 2023
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2006, United States

    Description

    Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026

    Reason

    The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size 26mm, +3 Trial Head.

    Code Info

    UDI-DI: 07613327188660; Lot Number: G7207242

    Distribution

    International distribution in the country of Ireland.

    Quantity

    2 units