Recall archive / FDA device enforcement
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS. — FDA record Z-0314-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 26, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
- 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.
- Classification
- Class II
- Recalling firm
- OSSTEM Implant Co., Ltd.
- Quantity
- N/A
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0314-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI Codes: 08800000995601 and 08800000995618. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 12, 2025
- Recall initiation date
- Aug 26, 2025
- Center classification date
- Nov 5, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.