The Vertex Max Drill Tube is a component within the Navigated Vertex… — Class II medical device recall Z-0441-2013
Terminated recall by Medtronic Navigation, Inc., reported 2012-12-05, distributed nationwide. Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation System due to a d
| Recall number | Z-0441-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2012-11-13 |
| Classified | 2012-11-29 |
| Reported by FDA | 2012-12-05 |
| Terminated | 2013-01-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, KR, LB, SA |
| Quantity | 12 units |
| Lot numbers | 120203 |
| Model numbers | 9733370 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0441-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.