BEUDAMED
    FDA Enforcement Class II Ongoing

    TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)

    Recall: Z-1261-2023 · Reported March 22, 2023

    Enforcement

    Recall Number
    Z-1261-2023
    Event ID
    91613
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Limacorporate S.p.A
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 22, 2023
    Initiation Date
    January 25, 2023
    Classification Date
    March 16, 2023
    Address
    Via Nazionale 52, Di San Daniele, San Daniele Del Friuli, N/A, N/A, Italy

    Description

    TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)

    Reason

    Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.

    Code Info

    Product Code: 1590.15.010 UDI-DI Code: 08033390128865 Lot Number: 2115522 Sterilization Lot Number: 2100241

    Distribution

    U.S. Distribution to: TX

    Quantity

    5 systems