[pending] Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
Pending LLM rewrite. Source: FDA_DEVICE Z-0315-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
- Manufacturer
- OSSTEM Implant Co., Ltd.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI Codes: 08800000996059 and 08800000996042.
Distribution
Distribution scope not specified by the agency.
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