Device recall
Z-3057-2017: Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit…
FDA device recall · Class II · Medtronic Navigation, Inc.
Key facts
| Recall number (Z-number) | Z-3057-2017 |
|---|---|
| Recall event | 77739 |
| Product | Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. 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… |
| 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