OSSTEM Implant Co., Ltd.: Medical Device Recall in 2025 - (Recall #: Z-0313-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 26, 2025

Date Posted: November 12, 2025

Recall Number: Z-0313-2026

Event ID: 97869

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.

Status: Ongoing

Product Quantity: N/A

Code Information:

UDI Codes: 08800000995793 and 08800000995526.

Distribution Pattern:

U.S.

Voluntary or Mandated:

FDA Mandated