Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
This recall is currently active, issued November 5, 2025. It was issued by Osstem Implant Co., Ltd. 66-16 Bansong-Ro 513Beon-Gil Busan City Haeundae District Korea (The Republic Of).
- Recall Initiated
- August 26, 2025
- Posted
- November 5, 2025
- Recall Number
- Z-0315-2026
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
U.S.
Lot / Code Info
UDI Codes: 08800000996059 and 08800000996042.
Root Cause
Radiation Control for Health and Safety Act
Action Taken
Osstem Implant issued notification to customers, titled "URGENT: MEDICAL DEVICE CORRECTION", dated 08/26/2025, provided reason for recall, product description with UDI codes, corrective action, product disposition and contact information.