Device recall
Z-0441-2013: The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill…
FDA device recall · Class II · Medtronic Navigation, Inc.
Key facts
| Recall number (Z-number) | Z-0441-2013 |
|---|---|
| Recall event | 63722 |
| Product | The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. The device… |
| Product code | HAW |
| Recalling firm | Medtronic Navigation, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 4, 2013 |
| 510(k) numbers | K050438 |
| 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