Device recall
Z-0708-2020: Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile…
FDA device recall · Class II · RHONDIUM LIMITED
Key facts
| Recall number (Z-number) | Z-0708-2020 |
|---|---|
| Recall event | 84126 |
| Product | Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondium Ltd., Katikati, New Zealand. |
| Product code | EBF |
| Recalling firm | RHONDIUM LIMITED |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K143694 |
| FEI number | 3011789026 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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