Medtronic Navigation, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0441-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: November 13, 2012

Date Posted: December 5, 2012

Recall Number: Z-0441-2013

Event ID: 63722

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.

Status: Terminated

Product Quantity: 12 Units

Code Information:

Lot number 120203.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated