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OSSTEM Implant Co., Ltd. recalls Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
Recalled November 12, 2025 · FDA recall Z-0314-2026 · OSSTEM Implant
Hazard
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 Class II
Units
N/A
Sold at
U.S.
Description
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 T2. Product Model Numbers T2-C and T2-CS.
Manufacturer(s)
OSSTEM Implant Co., Ltd.
Made in
Korea (the Republic of)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →