—#94876

Product

Vertex Max Drill Guide, Catalog Number 9732355, to be used with a Medtronic Computer-Assisted Surgery System to help assist with screw placement during spine procedures. To be used with a Medtronic Computer-Assisted Surgery System to help assist with screw placement during spine procedures.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K050438
Affected lot / code info: Lot number 100526

Why it was recalled

Drill guide handle may detach unintentionally during use.

Root cause (FDA determination)

Other

Action the firm took

Medtronic Navigation sent a "Product Correction Notification" letter dated September 22, 2010 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to set aside and do not use the Vertex Max Drill Guide 9732355, Lot Number 100526 and complete and return the Verification of Field Action Completion form via email: steve.murray@medtronic.com or fax: 720-890-3517. A Medtronic representative will contact the customer, visit their facility, remove the defective product, and provide a replacement Vertex Max Drill Guide that is correctly manufactured. For further information or if you have questions regarding use of the Vertex Max Drill Guide, please contact Medtronic Navigation Technical Services at 1-800-595-9709.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: USA including states of DC, IN, PA, and VA and country of Japan.

Timeline

Recall initiated: 2010-09-24
Posted by FDA: 2010-10-26
Terminated: 2011-04-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94876. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.