BEUDAMED
    FDA Enforcement Class II Ongoing

    TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.

    Recall: Z-0744-2025 · Reported January 1, 2025

    Enforcement

    Recall Number
    Z-0744-2025
    Event ID
    95732
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Limacorporate S.p.A
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 1, 2025
    Initiation Date
    October 2, 2024
    Classification Date
    December 20, 2024
    Address
    Via Nazionale 52, Di San Daniele, San Daniele Del Friuli, N/A, Italy

    Description

    TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.

    Reason

    Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.

    Code Info

    Product/Catalog Numbers: 1590.15.010 TEMA ELBOW - AXLE SMALL UDI-DI code: 08033390128865 Lot/Serial Numbers: 23031752300054 23177372300230 23173852400087 Product/Catalog Number: 1590.15.020 TEMA ELBOW - AXLE LARGE UDI-DI code: 08033390128872 Lot/Serial Numbers: 22276962300054 23325482400047 24006192400193

    Distribution

    U.S: FL and TX O.U.S.: N/A

    Quantity

    ~87 devices (U.S.)