BEUDAMED
    FDA Enforcement Class II Ongoing

    Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.

    Recall: Z-1987-2025 · Reported June 25, 2025

    Enforcement

    Recall Number
    Z-1987-2025
    Event ID
    96671
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Preat Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 25, 2025
    Initiation Date
    April 2, 2025
    Classification Date
    June 18, 2025
    Address
    2625 Skyway Dr Ste B, N/A, Santa Maria, CA, 93455-1405, United States

    Description

    Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.

    Reason

    Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant.

    Code Info

    Model Number: 9001767-F UDI-DI code: 00842092166093 Lot Numbers: CN932775 ED11-202416933 ED11-20249907 ED11-202435949 CN939348 ED11-202417239 ED11-202411745 ED11-202436404 CN945176 ED11-202419976 ED11-202413957 ED11-202437437 CN946712 ED11-202422121 ED11-202414696 ED11-202437710 TEC29015668 ED11-202422577 ED11-202416838 ED11-202437908 29018601 ED11-202428254 ED11-202433998 ED11-202449612 RD10511988 ED11-202428428 ED11-202435120 242070 2905742 ED11-20249819 ED11-202435909 20-607-UCHE-000603 8-663465-000743 3-16287-002239 14-493GARIEPY-000488 20-769300-000697 20-663461ROBI-000707 30-15958-002006 7-804684-001981 13-766227-000633 6-662469CARM-000576 20-15117-001341 22-790909-001273 8-489686-000448 30-Y097-002143 19-14364-001061 10-788120-001206 7-754951-000206 3-RIEHL-001837 CO19-2024-91576 CO19-2024-68877 CO19-2024-36953 CO19-2024-24127

    Distribution

    U.S. Nationwide distribution in the states of AZ, CA, GA, MO, NJ, NY, OH, PA, RI, TN,TX, and WA.

    Quantity

    145 abutments