—#114623

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. .

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K050438
Affected lot / code info: Lot number 120203.

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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 .

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 826 Coal Creek Cir, Louisville, Colorado 80027-9710

Distribution

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.

Timeline

Recall initiated: 2012-11-13
Posted by FDA: 2012-11-29
Terminated: 2013-01-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114623. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.