BEUDAMED
    FDA Recall Completed

    TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    Recall: Z-2094-2025 · Initiated January 19, 2024

    Recall

    Recall Number
    Z-2094-2025
    Event Number
    97021
    Firm
    STRATASYS LTD
    FEI Number
    3017374693
    Product Code
    EBI
    Status
    Completed
    Root Cause
    Software design
    Initiated
    January 19, 2024
    Posted
    July 7, 2025
    Address
    1 Holtzman St, Rehovot Israel

    Description

    TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    Reason

    Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.

    Action

    The firm initiated the recall to the consignee level on January 15, 2024. Customers were asked to coordinate a cartridge replacement. The reporting of this recall was done by the firm retroactively; the issue was resolved in January 2024.

    Distribution

    US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, Nebraska, New York, North Carolina, North Dakota, Oklahoma, Oregon, Utah, Wisconsin.

    Quantity

    109