—#44173

Product

AxiEM EM Knee Kit, and associated workstation.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K001284, K043088
Affected lot / code info: Catalog Number: 9732140. Lot numbers 2005100642 and 2005100645.

Why it was recalled

Knee Navigation Disposable Kits were programmed with an incorrect identification number on the tracker ROM chip which would not permit navigation during surgery.

Root cause (FDA determination)

Other

Action the firm took

Medtronic field personnel were notified by letter on 02/01/2006 and instructed to immediately contact each affected site and schedule an upgrade with the revised firmware

Recalling firm

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

Distribution

Distribution pattern: AZ, CA, CO, GA, IL, LA, MT, NE, NV, OH, TX. No military or government distribution. Foreign distribution to Australia, Austria, Israel, Singapore, Switzerland, UK.

Timeline

Recall initiated: 2006-02-01
Posted by FDA: 2006-04-07
Terminated: 2006-04-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #44173. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.