Class II — OSSTEM Implant Co., Ltd.
| Recalling firm | Osstem Implant Co., Ltd. |
|---|---|
| Registered facility | OSSTEM IMPLANT CO., LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P. |
| Quantity | N/A |
| Distribution | U.S. |
| Initiated | 2025-08-26 |
| Classified | 2025-11-05 |
| Recall number | Z-0315-2026 |
| Initiation | FDA Mandated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — OSSTEM Implant Co., Ltd. (Z-0315-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97869/
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