Device recall
Z-1539-2012: Mitaka Point Setter, holding system for surgical instruments. Holding surgical…
FDA device recall · Class II · Mitaka USA, Inc.
Key facts
| Recall number (Z-number) | Z-1539-2012 |
|---|---|
| Recall event | 52454 |
| Product | Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating procedures. |
| Product code | GWG |
| Recalling firm | Mitaka USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 22, 2012 |
| 510(k) numbers | K984355 |
| FEI number | 3002996788 |
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