Osstem recalls dental X-ray system T2Plus models T2-C-P and T2-CS-P due to potential missing FDA certification label. This may affect compliance with radiological safety standards.
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.
Osstem is recalling its dental X-ray systems T2Plus (model numbers T2-C-P and T2-CS-P) because the required FDA certification label might be missing. This could mean the device doesn't meet safety standards for radiological health.
The device may lack a required FDA certification label that confirms compliance with radiological safety standards. This omission could mean the X-ray system doesn't meet the necessary safety requirements for use in dental settings.
Dental clinics and dental professionals using the Osstem T2Plus X-ray systems with model numbers T2-C-P or T2-CS-P are most at risk. The recall affects devices sold in the U.S. market.
Check for model numbers T2-C-P or T2-CS-P on the Osstem Dental X-Ray System T2Plus. The UDI codes 08800000996059 and 08800000996042 also identify the affected units.
Look for the required FDA certification label on the device. If missing, contact Osstem for guidance.
The recall is because the required FDA certification label may be missing, which could affect compliance with radiological safety standards.
The affected model numbers are T2-C-P and T2-CS-P for the Osstem Dental X-Ray System T2Plus.
No, but you should check for the missing label and contact Osstem if you find it missing.
We’ve drafted a message you can send Osstem to request your refund or repair — edit it as you like.
Subject: Recall Z-0315-2026 — Osstem Osstem Hello, I own a Osstem that is covered by recall Z-0315-2026 from Osstem. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
