Z-0315-2026Class II

Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P

Name: Z-0315-2026 Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P
Creator: OSSTEM Implant Co., Ltd.
Published: 2025-08-26
License: https://open.fda.gov/license/

OSSTEM Implant Co., Ltd. / initiated 2025-08-26 / Open, Classified / root cause: labeling and UDI

FDA source

OSSTEM Implant Co., Ltd. began a recall of Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P on 2025-08-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0315-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-26
Posted: 2025-11-05
Recalling firm: OSSTEM Implant Co., Ltd.
Product: Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
Product code: OAS X-Ray, Tomography, Computed, Dental
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.
Root cause tag: labeling and UDI
FDA root cause: Radiation Control for Health and Safety Act
Action: 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.
Distribution: U.S.
Product codes and lots: UDI Codes: 08800000996059 and 08800000996042.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0315-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0313-2026	Class II	Ongoing	FDA Mandated	2025-11-12	2025-11-05
Z-0314-2026	Class II	Ongoing	FDA Mandated	2025-11-12	2025-11-05
Z-0315-2026	Class II	Ongoing	FDA Mandated	2025-11-12	2025-11-05

Product code OAS

K233806Class IIT2 PlusOsstem Implant Co., Ltd. / cleared 2024-09-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)