Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI Codes: 08800000995601 and 08800000995618.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- OSSTEM Implant Co., Ltd.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
Product Codes/Lot Numbers:
UDI Codes: 08800000995601 and 08800000995618.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0314-2026
Related Recalls
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
OSSTEM Implant Co.
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 Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
OSSTEM Implant Co.
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.