Z-0718-06

AxiEM EM Knee Kit, and associated workstation

Name: Z-0718-06 AxiEM EM Knee Kit, and associated workstation
Creator: Medtronic Navigation, Inc
Published: 2006-02-01
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2006-02-01 / Terminated

FDA source

Medtronic Navigation, Inc began a recall of AxiEM EM Knee Kit, and associated workstation on 2006-02-01. The reason FDA records is "Knee Navigation Disposable Kits were programmed with an incorrect identification number on the tracker ROM chip which would not permit navigation during surgery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0718-06
Status: Terminated
Initiated: 2006-02-01
Posted: 2006-04-07
Terminated: 2006-04-06
Recalling firm: Medtronic Navigation, Inc
Product: AxiEM EM Knee Kit, and associated workstation.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Knee Navigation Disposable Kits were programmed with an incorrect identification number on the tracker ROM chip which would not permit navigation during surgery.
FDA root cause: Other
Action: 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
Quantity in commerce: 84 kits
Distribution: 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.
Product codes and lots: Catalog Number: 9732140. Lot numbers 2005100642 and 2005100645.

Product code HAW

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)