Z-0313-2026 Class II Ongoing
FDA device recall Z-0313-2026 was initiated by OSSTEM Implant Co., Ltd. on August 26, 2025 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- November 12, 2025
- Initiation Date
- August 26, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- N/A
Product Description
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 Pattern
U.S.
Code Information
UDI Codes: 08800000995793 and 08800000995526.