Device recall
Z-0050-2025: StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The…
FDA device recall · Class II · Medtronic Navigation, Inc.
Key facts
| Recall number (Z-number) | Z-0050-2025 |
|---|---|
| Recall event | 95283 |
| Product | StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. |
| Product code | OLO |
| Recalling firm | Medtronic Navigation, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K201189 |
| FEI number | 1000517638 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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