Osstem Dental X-Ray System T1 — Class II medical device recall Z-0313-2026
Ongoing recall by OSSTEM Implant Co., Ltd., reported 2025-11-12. Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling f
| Recall number | Z-0313-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | OSSTEM Implant Co., Ltd., Haeundae District, N/A, Korea (the Republic of) |
| Recall initiated | 2025-08-26 |
| Classified | 2025-11-05 |
| Reported by FDA | 2025-11-12 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 08800000995526, 08800000995793 |
| Model numbers | T1-C, T1-CS |
Product
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0313-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.