Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
FDA Device Recall #Z-0315-2026 — Class II — August 26, 2025
Recall Summary
| Recall Number | Z-0315-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 26, 2025 |
| Status | Ongoing |
| Voluntary | FDA Mandated |
Recalling Firm
| Firm | OSSTEM Implant Co., Ltd. |
| Location | Haeundae District, N/A |
| Product Type | Devices |
| Quantity | N/A |
Product Description
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
Reason for Recall
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.
Distribution Pattern
U.S.
Lot / Code Information
UDI Codes: 08800000996059 and 08800000996042.
Other Recalls from OSSTEM Implant Co., Ltd.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0314-2026 | Class II | Osstem Dental X-Ray System T2. Product Model Nu... | Aug 26, 2025 |
| Z-0313-2026 | Class II | Osstem Dental X-Ray System T1. Product Model Nu... | Aug 26, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.