Official recall record
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-08-26
- Country of alert
- Korea (the Republic of)
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 08800000995601
- Brand on record
- OSSTEM Implant Co., Ltd.
What the authority reported
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 to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2025-08-26 · US FDA — Medical Devices
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.