Z-0145-2011

Vertex Max Drill Guide, Catalog Number 9732355, to be used with a Medtronic Computer-Assisted Surgery System...

Name: Z-0145-2011 Vertex Max Drill Guide, Catalog Number 9732355, to be used with a Medtronic Computer-Assisted Surgery System...
Creator: Medtronic Navigation, Inc
Published: 2010-09-24
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2010-09-24 / Terminated

FDA source

Medtronic Navigation, Inc began a recall of Vertex Max Drill Guide, Catalog Number 9732355, to be used with a Medtronic Computer-Assisted Surgery System to help assist with screw placement during spine... on 2010-09-24. The reason FDA records is "Drill guide handle may detach unintentionally during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0145-2011
Status: Terminated
Initiated: 2010-09-24
Posted: 2010-10-26
Terminated: 2011-04-13
Recalling firm: Medtronic Navigation, Inc
Product: Vertex Max Drill Guide, Catalog Number 9732355, to be used with a Medtronic Computer-Assisted Surgery System to help assist with screw placement during spine procedures. To be used with a Medtronic Computer-Assisted Surgery System to help assist with screw placement during spine procedures.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Drill guide handle may detach unintentionally during use.
FDA root cause: Other
Action: Medtronic Navigation sent a "Product Correction Notification" letter dated September 22, 2010 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to set aside and do not use the Vertex Max Drill Guide 9732355, Lot Number 100526 and complete and return the Verification of Field Action Completion form via email: [email protected] or fax: 720-890-3517. A Medtronic representative will contact the customer, visit their facility, remove the defective product, and provide a replacement Vertex Max Drill Guide that is correctly manufactured. For further information or if you have questions regarding use of the Vertex Max Drill Guide, please contact Medtronic Navigation Technical Services at 1-800-595-9709.
Quantity in commerce: 8 units
Distribution: Worldwide distribution: USA including states of DC, IN, PA, and VA and country of Japan.
Product codes and lots: Lot number 100526

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)