Device recall
Z-2672-2016: Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS…
FDA device recall · Class II · Nakanishi Inc.
Key facts
| Recall number (Z-number) | Z-2672-2016 |
|---|---|
| Recall event | 74666 |
| Product | Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150). The intended use of the tips is based on the parent device. For the ultrasonic scalers and the sonic air scaler, the tips are used for various actions such as scaling… |
| Product code | ELC |
| Recalling firm | Nakanishi Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 25, 2018 |
| 510(k) numbers | K031421 |
| FEI number | 3002807687 |
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