Device recall
Z-1824-2020: Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial…
FDA device recall · Class II · Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Key facts
| Recall number (Z-number) | Z-1824-2020 |
|---|---|
| Recall event | 85284 |
| Product | Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is to be used for the cementation of indirect restorations including veneers, inlays, onlays, bridges, posts, and the cementation of crown restorations to… |
| Product code | EMA |
| Recalling firm | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 19, 2021 |
| 510(k) numbers | K001899, K191548 |
| FEI number | 2024312 |
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