Device recall
Z-3016-2026: Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product…
FDA device recall · Class II · Henry Schein Inc.
Key facts
| Recall number (Z-number) | Z-3016-2026 |
|---|---|
| Recall event | 99465 |
| Product | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product Code 1840; Lots 2529604, 2538147, 2608145 2) 949-3595, Mfr Product Code 1841; Lots 2539075, 2539313, 2609789, 2539065 3) 949-3596, Mfr Product Code 1842; Lots 2536632, 2609174, 2610099 4)… |
| Product code | EBF |
| Recalling firm | Henry Schein Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K051867 |
| FEI number | 1000143438 |
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