Device recall
Z-2673-2016: Diamond Coated Tips and Burs are accessories to the air powered Bone drill…
FDA device recall · Class II · Nakanishi Inc.
Key facts
| Recall number (Z-number) | Z-2673-2016 |
|---|---|
| Recall event | 74666 |
| Product | Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light) The intended use of the tips is based on the parent device. For the VarioSurg, in addition to the scaling functions, diamond coated tips are used for socket lift, sinus lift, and implant… |
| Product code | ELC |
| Recalling firm | Nakanishi Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 25, 2018 |
| 510(k) numbers | K073678 |
| 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