Osstem
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Osstem and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-11-12FDA-DeviceClass IIOsstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
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.
- 2025-11-12FDA-DeviceClass IIOsstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
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.
- 2025-11-12FDA-DeviceClass IIOsstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
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.
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