OSSTEM Implant Co., Ltd.: Device Recall

Recall Details

Recall Number

Z-0313-2026

Classification

Class II

Product Type

Device

Recalling Firm

OSSTEM Implant Co., Ltd.

Status

Ongoing

Date Initiated

08/26/2025

Location

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

Voluntary/Mandated

FDA Mandated

Product Quantity

N/A

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.

Product Description

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

Distribution Pattern

U.S.

Other Recalls by OSSTEM Implant Co., Ltd.

• Class II: Risk 08/26/2025
  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.
• Class II: Risk 08/26/2025
  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.

View all recalls by OSSTEM Implant Co., Ltd. →