Device recall
Z-3054-2017: Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the…
FDA device recall · Class II · Medtronic Navigation, Inc.
Key facts
| Recall number (Z-number) | Z-3054-2017 |
|---|---|
| Recall event | 77739 |
| Product | Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an… |
| Product code | PGW |
| Recalling firm | Medtronic Navigation, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 3, 2018 |
| 510(k) numbers | K153555 |
| FEI number | 1000517638 |
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