FDA Device

AxiEM EM Knee Kit, and associated workstation.

Hazard

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

What You Should Do

Remedy

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

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Products

AxiEM EM Knee Kit, and associated workstation.
Brand
Medtronic Navigation, Inc
UPC
Catalog Number: 9732140. Lot numbers 2005100642 and 2005100645.

Units Affected

84 kits

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