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Terminated

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. .

FDA Recall Z-0441-2013 · Posted 2012-11-29

Recall StatusTerminated
Product CodeHAW
Date Initiated2012-11-13
Date Terminated2013-01-04
Product Quantity12 Units

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.

Firm 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 .

Root Cause

Process control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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