FDA Device recall Z-0441-2013
The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370)
- FDA Device
- Class II
- terminated
- Published 2012-12-05
On 2012-12-05 the FDA classified a Class II recall of The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370) by Medtronic Navigation, citing medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation System due to a defect related to the internal threading for component set up.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0441-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-13 |
| Published | 2012-12-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Navigation |
| Distribution | US |
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 is reusable and requires sterilization according to product labeling. .
Reason
Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation System due to a defect related to the internal threading for component set up.
Identifiers
| code_info | Lot number 120203. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0441-2013%22
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