Device recall
Z-2943-2020: Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia…
FDA device recall · Class II · Talladium Inc
Key facts
| Recall number (Z-number) | Z-2943-2020 |
|---|---|
| Recall event | 86227 |
| Product | Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-ceramic (no metal) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized… |
| Product code | EIH |
| Recalling firm | Talladium Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 7, 2022 |
| 510(k) numbers | K100232 |
| FEI number | 2023129 |
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