Device recall
Z-1883-2018: Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model…
FDA device recall · Class II · Coltene Whaledent Inc
Key facts
| Recall number (Z-number) | Z-1883-2018 |
|---|---|
| Recall event | 79994 |
| Product | Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone. |
| Product code | EJL |
| Recalling firm | Coltene Whaledent Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 8, 2019 |
| FEI number | 2416455 |
At a glance
- None 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