Device 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. .
Z-0441-2013
Product summary
- Event
- Event 63722
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 Units
- Official record key
device-enforcement:Z-0441-2013
Official wording
Reason: 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.
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.
Derived failure modes
-
Unknown
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.