OSSTEM Implant Co., Ltd. recalls Osstem Dental X-Ray System T2. Product
- Recalling company
- OSSTEM Implant Co., Ltd.
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Aug 26, 2025
- Reported
- Nov 12, 2025
- Distribution
- U.S.
- Status
- Ongoing
- Quantity
- N/A
- Lot / codes
- UDI Codes: 08800000995601 and 08800000995618.
- Company location
- Haeundae District, N/A
- Recall type
- FDA Mandated
- Recall number
- Z-0314-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0314-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.