FDA recall Z-0313-2026

Product

Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.

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.

Distribution

U.S.

Key facts

Status

Ongoing

Initiation date

2025-08-26

Report date

2025-11-12

Voluntary/Mandated

FDA Mandated

Location

Haeundae District, N/A, Korea (the Republic of)

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0313-2026