BEUDAMED
    FDA Enforcement Class II Ongoing

    PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610

    Recall: Z-0524-2024 · Reported December 20, 2023

    Enforcement

    Recall Number
    Z-0524-2024
    Event ID
    93329
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Limacorporate S.p.A
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 20, 2023
    Initiation Date
    October 27, 2023
    Classification Date
    December 9, 2023
    Address
    Via Nazionale 52, Di San Daniele, San Daniele Del Friuli, N/A, N/A, Italy

    Description

    PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610

    Reason

    Due to incorrect product labeling

    Code Info

    Product Code: 6539.54.610 UDI-DI Code: 08033390212786 Lot/Sterilization Numbers: 2122621 / 2200149 2203871 / 2200167

    Distribution

    U.S Distribution: AZ, CA, IL, LA, and NY

    Quantity

    33 devices