BEUDAMED
    FDA Enforcement Class II Ongoing

    Neodent GM X 6mm Engaging Titanium Base, REF: 9007162

    Recall: Z-1285-2023 · Reported April 5, 2023

    Enforcement

    Recall Number
    Z-1285-2023
    Event ID
    91876
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Preat Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 5, 2023
    Initiation Date
    February 21, 2023
    Classification Date
    March 24, 2023
    Address
    2625 Skyway Dr Ste B, N/A, Santa Maria, CA, 93455-1405, United States

    Description

    Neodent GM X 6mm Engaging Titanium Base, REF: 9007162

    Reason

    Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient.

    Code Info

    UDI: 00842092161326, Lots: 211891 and 211912

    Distribution

    US Nationwide distribution in the states of TX, OR, UT, NY.

    Quantity

    26