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U.S. Department of Health and Human Services

Class 2 Device Recall T2

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 Class 2 Device Recall T2see related information
Date Initiated by FirmAugust 26, 2025
Date PostedNovember 05, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0314-2026
Recall Event ID 97869
510(K)NumberK212303 
Product Classification X-ray, tomography, computed, dental - Product Code OAS
ProductOsstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
Code Information UDI Codes: 08800000995601 and 08800000995618.
Recalling Firm/
Manufacturer		 OSSTEM Implant Co., Ltd.
66-16 Bansong-Ro 513beon-Gil
Busan City
Haeundae District Korea (the Republic of)
Manufacturer 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.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionOsstem 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.
DistributionU.S.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OAS
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