—#95728

Product

Polaris Spectra System Control Unit, a component of the StealthStation S7 System. Medtronic Navigation, Louisville, CO 80027. Intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K050438
Affected lot / code info: Lots received from NDI (supplier) between May 1, 2020, and July 31, 2010.

Why it was recalled

Electronic surgical navigation aid may lose tracking ability or stop working.

Root cause (FDA determination)

Component design/selection

Action the firm took

Customers were notified by a Product Correction Notification letter on 11/05/2010. The letter advised customers of the affected product, the potential problem, and the description of the correction. Customers were told that a Medtronic rep will visit them to install a replacement control unit. Further information is available at 800-595-9709 or 720-890-3200.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- US, including states of AL, AZ, CO, FL, GA, KY, MD, MN, NE, PA, TX, WI, and MD and countries of Australia, Belgium, Canada, Czech Republic, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, South Korea, Spain, Turkey, and UAE.

Timeline

Recall initiated: 2010-11-05
Posted by FDA: 2010-12-17
Terminated: 2011-05-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95728. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.