BEUDAMED
    FDA Enforcement Class II Ongoing

    HIGH V+ Spinal Cement System REF T040321K

    Recall: Z-1099-2023 · Reported February 15, 2023

    Enforcement

    Recall Number
    Z-1099-2023
    Event ID
    91493
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    TEKNIMED SAS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 15, 2023
    Initiation Date
    December 15, 2022
    Classification Date
    February 6, 2023
    Address
    Zone Industrielle Montredone, 11 Rue D Apollo, L'Union, N/A, France

    Description

    HIGH V+ Spinal Cement System REF T040321K

    Reason

    Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.

    Code Info

    Model/Part Number: T040321K UDI-DI Code: 03760177043084 Batch Number: 060422382

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the state of MS and the countries of Poland, Lithuania, Spain, Taiwan, South Africa, Israel.

    Quantity

    236 systems