Device recall
Z-0221-2019: Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA…
FDA device recall · Class II · Nakanishi Inc.
Key facts
| Recall number (Z-number) | Z-0221-2019 |
|---|---|
| Recall event | 80713 |
| Product | Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible. |
| Product code | KMW |
| Recalling firm | Nakanishi Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2021 |
| 510(k) numbers | K171155 |
| 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