Device recall
Z-0552-2019: StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial…
FDA device recall · Class I · Medtronic Navigation, Inc.
Key facts
| Recall number (Z-number) | Z-0552-2019 |
|---|---|
| Recall event | 81214 |
| Product | StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc. Biopsy Needle Kit… |
| Product code | HAW |
| Recalling firm | Medtronic Navigation, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 5, 2024 |
| 510(k) numbers | K150216, K153660 |
| 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