Haeundae District, N/A, Korea (the Republic of)
OSSTEM Implant Co., Ltd. recalls
1 recall recorded since 2018, most recently on 26 August 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 26 August 2025
- Reason
- 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.
- Initiated
- FDA Mandated
- Recall numbers
- Z-0314-2026, Z-0313-2026, Z-0315-2026
- Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
- Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
- Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.