T2 PlusRecalls & reported problems across all models

We found 2 models of T2 Plus by Osstem Implant Co.,Ltd. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

T2 Plus recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 26, 2025Open, Classified

   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.

   Z-0315-2026 · Root cause: Radiation Control for Health and Safety Act · names 2 of these models · Recall details · FDA record ↗

T2 Plus models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• T2 Plus T2-CS-P

  X-Ray, Tomography, Computed, Dental
  1 recall0 reports
• T2 Plus T2-C-P

  X-Ray, Tomography, Computed, Dental
  1 recall0 reports