BEUDAMED
    FDA Enforcement Class II Ongoing

    NexxZr T Multi A3.5 W98-16mm, REF: 745451

    Recall: Z-2356-2026 · Reported June 17, 2026

    Enforcement

    Recall Number
    Z-2356-2026
    Event ID
    98823
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Sagemax Bioceramics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2026
    Initiation Date
    December 11, 2025
    Classification Date
    June 9, 2026
    Address
    34210 9th Ave S Ste 118, N/A, Federal Way, WA, 98003-6790, United States

    Description

    NexxZr T Multi A3.5 W98-16mm, REF: 745451

    Reason

    Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress.

    Code Info

    UDI-DI: 00842271175373, Lot: YBDGLD

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, MO, MN, NY, FL, ID and the countries of AT, CZ, DE, EE, EG, FR, GR, ID, IT, KZ, RS, SE, SI, TZ, VN.

    Quantity

    113