Device recall
Z-0314-2026: Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
FDA device recall · Class II · OSSTEM Implant Co., Ltd.
Key facts
| Recall number (Z-number) | Z-0314-2026 |
|---|---|
| Recall event | 97869 |
| Product | Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS. |
| Product code | OAS |
| Recalling firm | OSSTEM Implant Co., Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K212303 |
| FEI number | 3003394081 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database