FDA Medical devices recall ·
Osstem Dental X-Ray System T2Plus recall
- Recall number
- Z-0315-2026
- Date
- (initiated August 26, 2025)
- Company / brand
- OSSTEM Implant Co., Ltd.
66-16 Bansong-Ro 513beon-Gil, Haeundae District, N/A, Korea (the Republic of) - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- N/A
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI Codes: 08800000996059 and 08800000996042.
Distribution
U.S.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0315-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.