BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117

    Recall: Z-0417-2026 · Reported November 12, 2025

    Enforcement

    Recall Number
    Z-0417-2026
    Event ID
    97720
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Prismatik Dentalcraft, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 12, 2025
    Initiation Date
    September 30, 2025
    Classification Date
    November 3, 2025
    Address
    2144 Michelson Dr, N/A, Irvine, CA, 92612-1304, United States

    Description

    Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117

    Reason

    Incorrect titanium screw, packaged with dental implant.

    Code Info

    Lot Code: Product Catalog Number (SKU#): 70-1047-COM0117 UDI: +D745701047COM01170/$$80176270484/16D20250722E Lot Number: 6270484, 6271089

    Distribution

    US Distribution to states of: California, Colorado, Connecticut, Florida, Georgia, Hawaii, Kentucky, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina, Tennessee, Virginia, Washington.

    Quantity

    208 units