BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1285-2023 · Initiated February 21, 2023

    Recall

    Recall Number
    Z-1285-2023
    Event Number
    91876
    Firm
    Preat Corp
    FEI Number
    2918719
    Product Code
    NHA
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    February 21, 2023
    Posted
    March 24, 2023
    Address
    2625 Skyway Dr, Ste B, Santa Maria, CA, 93455-1405

    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.

    Action

    On 2/21/23, recall notices were mailed to customers who were asked to discard or return affected devices to the recalling firm. In addition, in the event affected product was further distributed, customers were asked to inform their customers, or to provide a customer list so the recalling firm could notify these additional customers. The customer service number was provided: 800-232-7732

    Distribution

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

    Quantity

    26