Medtronic Navigation, Inc AxiEM EM Knee Kit, and associated workstation. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AxiEM EM Knee Kit, and associated workstation.
Brand
Medtronic Navigation, Inc
Lot Codes / Batch Numbers
Catalog Number: 9732140. Lot numbers 2005100642 and 2005100645.
Products Sold
Catalog Number: 9732140. Lot numbers 2005100642 and 2005100645.
Medtronic Navigation, Inc is recalling AxiEM EM Knee Kit, and associated workstation. due to Knee Navigation Disposable Kits were programmed with an incorrect identification number on the tracker ROM chip which would not permit navigation duri. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Knee Navigation Disposable Kits were programmed with an incorrect identification number on the tracker ROM chip which would not permit navigation during surgery.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, GA, IL, LA, MT, NE, NV, OH, OR, TX
Page updated: Jan 10, 2026