Device recall
Z-2420-2020: HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam…
FDA device recall · Class II · Coltene Whaledent Inc
Key facts
| Recall number (Z-number) | Z-2420-2020 |
|---|---|
| Recall event | 85794 |
| Product | HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam. |
| Product code | EJG |
| Recalling firm | Coltene Whaledent Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 2416455 |
At a glance
- None 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