Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P. Recalled by OSSTEM Implant Co., Ltd. Due to Osstem Implant Co. Ltd, is voluntarily initiating a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact OSSTEM Implant Co., Ltd. directly.
Affected Products
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
Quantity: N/A
Why Was This 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.
Where Was This Sold?
U.S.
About OSSTEM Implant Co., Ltd.
OSSTEM Implant Co., Ltd. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report