BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2356-2026 · Initiated December 11, 2025

    Recall

    Recall Number
    Z-2356-2026
    Event Number
    98823
    Firm
    Sagemax Bioceramics, Inc.
    FEI Number
    3007518500
    Product Code
    EIH
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 11, 2025
    Posted
    June 9, 2026
    Address
    34210 9th Ave S, Ste 118, Federal Way, WA, 98003-6790

    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.

    Action

    On 12/11/2025, safety notices were emailed to customers who were asked to do the following: 1) Separate and block the affected device in your warehouse so that they can no longer be used. 2) Contact the recalling firm to arrange return. 3) Complete and return the response form via email to [email protected] Queries regarding the measures described in this Field Safety Notice should be addressed to [email protected]

    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