CLASS II ONGOING Device recall · Reported 12 Nov 2025 · FDA Enforcement Report
Osstem Dental X-Ray System T2Plus recalled by OSSTEM Implant Co
Osstem Implant is recalling Osstem Dental X-Ray System T2Plus. The recall was initiated on 26 Aug 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0315-2026
- FDA event ID
- 97869
- Recalling firm
- Osstem Implant, Haeundae District, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Aug 2025
- FDA classified
- 5 Nov 2025
- Reported
- 12 Nov 2025
- Type
- FDA Mandated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 26 Aug 2025 | Recall initiated by company | |
| 5 Nov 2025 | Classified by FDA | +71 days |
| 12 Nov 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
Where it was distributed
U.S.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI Codes: 08800000996059 and 08800000996042.
Where was it sold?
U.S.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 97869This product is part of a recall event; the main page for the event is Osstem Dental X-Ray System T2 recalled by OSSTEM Implant Co.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Osstem Dental X-Ray System T2 recalled by OSSTEM Implant Co | Osstem Implant | Other | N/A | |
| CLASS II | Osstem Dental X-Ray System T1 recalled by OSSTEM Implant Co | Osstem Implant | Other | N/A |
More recalls from Osstem Implant
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Osstem Dental X-Ray System T1 recalled by OSSTEM Implant Co | Osstem Implant | Other | N/A |
| Device | CLASS II | Osstem Dental X-Ray System T2 recalled by OSSTEM Implant Co | Osstem Implant | Other | N/A |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |