—#96537

Product

Vertex Max Drill Tube, Catalog Number 9733140, a component of the Navigated Vertex Max Drill Guide Kit, Catalog Number 9733370. Medtronic, Inc., Louisville, CO. Used in conjunction with the StealthStation navigation systems to assist in screw placement during spine surgery.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K050438
Affected lot / code info: Lot number: 100721

Why it was recalled

Incorrectly manufactured drill tube could cause incorrect screw placement during spinal surgery.

Root cause (FDA determination)

Component design/selection

Action the firm took

Consignees were notified by a Product Correction Notification letter on 12/15/2010 and given the affected product and a description of the problem. The letter stated that a Medtronic representative would contact customers to visit their facility and replace the affected guide with one that has been correctly manufactured. Additional information is available at 800-595-9709.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- USA, including states of GA, IL, IN, MN, MO, OH, OR, PA, and TX and countries of Denmark, Finland, Singapore, Spain, and UK.

Timeline

Recall initiated: 2010-12-15
Posted by FDA: 2011-02-04
Terminated: 2011-05-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96537. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.