OSSTEM Implant Co., Ltd. recalls Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
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…
Read the official notice →- Date
- 2025-11-12
- Country
- United States
- Brand
- OSSTEM Implant Co., Ltd.
- Product
- Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
- Classification
- Class II
- Units
- U.S.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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