OSSTEM Implant Co., Ltd. FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.Class IIAug 26, 2025Osstem Implant Co. Ltd, is voluntarily initiating a medical	Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling f	Class IIDevices	Aug 26, 2025
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.Class IIAug 26, 2025Osstem Implant Co. Ltd, is voluntarily initiating a medical	Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling f	Class IIDevices	Aug 26, 2025
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.Class IIAug 26, 2025Osstem Implant Co. Ltd, is voluntarily initiating a medical	Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling f	Class IIDevices	Aug 26, 2025