Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
FDA device recall Z-0315-2026 · posted 2025-11-05 · Open, Classified
Recall details
- Recalling firm
- OSSTEM Implant Co., Ltd.
- 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.
- Action taken
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- OAS
- Distribution
- U.S.
- Date initiated
- 2025-08-26
- Date posted
- 2025-11-05
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| T2 Plus (K233806) | Osstem Implant Co., Ltd. | 2024-09-06 |