# FDA recall Z-0313-2026

> **OSSTEM Implant Co., Ltd.** · Class II · device recall initiated 2025-08-26.

## 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

- **Recall number:** Z-0313-2026
- **Recalling firm:** OSSTEM Implant Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0313-2026. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-0313-2026. Source: US FDA. Licensed CC0.

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