Device recall
Z-2579-2023: Keystone Bosworth Copaliner Cavity Varnish.5oz (14 ml)- Intended to provide a…
FDA device recall · Class II · Keystone Industries
Key facts
| Recall number (Z-number) | Z-2579-2023 |
|---|---|
| Recall event | 92851 |
| Product | Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina Item No. 0921526 |
| Product code | LBH |
| Recalling firm | Keystone Industries |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K933505 |
| FEI number | 3010002722 |
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