Reported Nov 12, 2025 · Ongoing
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
OSSTEM Implant Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: OSSTEM Implant Co., Ltd. · 66-16 Bansong-Ro 513beon-Gil · Haeundae District, N/A · N/A
Is this the product you have?
- Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
- Lot codes and dates
- UDI Codes08800000996059 and 08800000996042
- Amount recalled
- N/A
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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