BEUDAMED
    FDA Recall Open, Classified

    Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.

    Recall: Z-0315-2026 · Initiated August 26, 2025

    Recall

    Recall Number
    Z-0315-2026
    Event Number
    97869
    Firm
    OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)
    FEI Number
    3003394081
    Product Code
    OAS
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    August 26, 2025
    Posted
    November 5, 2025

    Description

    Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.

    Reason

    Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.

    Action

    Osstem Implant issued notification to customers, titled "URGENT: MEDICAL DEVICE CORRECTION", dated 08/26/2025, provided reason for recall, product description with UDI codes, corrective action, product disposition and contact information.

    Distribution

    U.S.