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Recall Observatory FDA recall evidence

Device product

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

Z-0314-2026

August 26, 2025

Class II

Product summary

Firm
OSSTEM Implant Co., Ltd.
Event
Event 97869
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0314-2026

Official wording

Reason: 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.

Code information: UDI Codes: 08800000995601 and 08800000995618.

Distribution pattern: U.S.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.