OSSTEM Implant Co., Ltd. recalls Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.

Recall date

August 26, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0313-2026

FDA classification

Class II

Brand / firm

OSSTEM Implant Co., Ltd.

Sold / distributed

U.S.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.