BEUDAMED
    FDA Enforcement Class II Ongoing

    PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile

    Recall: Z-2024-2025 · Reported July 2, 2025

    Enforcement

    Recall Number
    Z-2024-2025
    Event ID
    96911
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Limacorporate S.p.A
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 2, 2025
    Initiation Date
    May 19, 2025
    Classification Date
    June 25, 2025
    Address
    Via Nazionale 52, Di San Daniele, San Daniele Del Friuli, N/A, Italy

    Description

    PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile

    Reason

    There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.

    Code Info

    Lot number 2416658/UDI: 08033390201827

    Distribution

    Worldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX and the countries of Italy, Poland, France.

    Quantity

    19 units