Z-0441-2013Class II

The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The...

Name: Z-0441-2013 The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The...
Creator: Medtronic Navigation, Inc.
Published: 2012-11-13
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2012-11-13 / Terminated / root cause: manufacturing process

FDA source

Medtronic Navigation, Inc. began a recall of 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... on 2012-11-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0441-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-13
Posted: 2012-11-29
Terminated: 2013-01-04
Recalling firm: Medtronic Navigation, Inc
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. .
Product code: HAW Neurological Stereotaxic Instrument
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medtronic Navigation sent a Urgent Medical Device Recall letter dated November 13 -14, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed do not use the Vertex Max Cannulated Drill Tube clinically. Medtronic Navigation will remove the Vertex Max Cannulated Drill Tube. Medtronic Navigation will provide a replacement Vertex.Max Cannulated Drill Tube manufactured from a different lot which was inspected to verify the defect has been corrected. If you have any questions about this notification, please contact a Sales Representative in your area. For further questions please call (720) 890-3200 Ext. 3303 .
Quantity in commerce: 12 Units
Distribution: Worldwide Distribution--US (nationwide) including the states of CA, FL, MA, LA, and MI and the countries of Switzerland, Saudi Arabia, Lebanon, Canada and Korea.
Product codes and lots: Lot number 120203.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0441-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0441-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-05	2012-11-29

Product code HAW

K050438Class IIStealthstation System UpdateMedtronic Surgical Navigation Technologies / cleared 2005-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)