BEUDAMED
    FDA Enforcement Class II Ongoing

    NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662

    Recall: Z-2514-2025 · Reported September 10, 2025

    Enforcement

    Recall Number
    Z-2514-2025
    Event ID
    97239
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Preat Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 10, 2025
    Initiation Date
    June 25, 2025
    Classification Date
    September 3, 2025
    Address
    2625 Skyway Dr Ste B, N/A, Santa Maria, CA, 93455-1405, United States

    Description

    NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662

    Reason

    Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correct orientation, resulting in restoration delay.

    Code Info

    UDI-DI: 00842092169599. Lot: 277097

    Distribution

    US Nationwide distribution in the states of NY, FL, PA, CA, OH.

    Quantity

    11