Z-1042-2011

Vertex Max Drill Tube, Catalog Number 9733140, a component of the Navigated Vertex Max Drill Guide Kit...

Name: Z-1042-2011 Vertex Max Drill Tube, Catalog Number 9733140, a component of the Navigated Vertex Max Drill Guide Kit...
Creator: Medtronic Navigation, Inc
Published: 2010-12-15
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2010-12-15 / Terminated / root cause: design

FDA source

Medtronic Navigation, Inc began a recall of Vertex Max Drill Tube, Catalog Number 9733140, a component of the Navigated Vertex Max Drill Guide Kit, Catalog Number 9733370. Medtronic, Inc., Louisville... on 2010-12-15. The reason FDA records is "Incorrectly manufactured drill tube could cause incorrect screw placement during spinal surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1042-2011
Status: Terminated
Initiated: 2010-12-15
Posted: 2011-02-04
Terminated: 2011-05-04
Recalling firm: Medtronic Navigation, Inc
Product: Vertex Max Drill Tube, Catalog Number 9733140, a component of the Navigated Vertex Max Drill Guide Kit, Catalog Number 9733370. Medtronic, Inc., Louisville, CO. Used in conjunction with the StealthStation navigation systems to assist in screw placement during spine surgery.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Incorrectly manufactured drill tube could cause incorrect screw placement during spinal surgery.
Root cause tag: design
FDA root cause: Component design/selection
Action: Consignees were notified by a Product Correction Notification letter on 12/15/2010 and given the affected product and a description of the problem. The letter stated that a Medtronic representative would contact customers to visit their facility and replace the affected guide with one that has been correctly manufactured. Additional information is available at 800-595-9709.
Quantity in commerce: 15 devices
Distribution: Worldwide Distribution -- USA, including states of GA, IL, IN, MN, MO, OH, OR, PA, and TX and countries of Denmark, Finland, Singapore, Spain, and UK.
Product codes and lots: Lot number: 100721

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)