Osstem Dental X-Ray System T1. Product Model Numbers recallZ-0313-2026 · OSSTEM Implant Co., Ltd. · initiated Aug 26, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from OSSTEM Implant Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
Osstem Implant issued notification to customers, titled "URGENT: MEDICAL DEVICE CORRECTION", dated 08/26/2025, provided reason for recall, product description with UDI codes, corrective action, product disposition and contact information.
Recall details
- Recall number
- Z-0313-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 26, 2025
- Posted by the FDA
- Nov 5, 2025
- Recalling firm
- OSSTEM Implant Co., Ltd.
- Product code
- OAS
- FDA submissions
- K183475
- Distribution
- U.S.
Product description
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
Code information (models, lots, serial numbers)
UDI Codes: 08800000995793 and 08800000995526.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
Other products in the same recall event
The FDA groups related products into one recall event (event 97869).
- Z-0314-2026 · Open, ClassifiedOsstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
- Z-0315-2026 · Open, ClassifiedOsstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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