Recall Z-0718-06 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc
AxiEM EM Knee Kit, and associated workstation.
| Date | Apr 7, 2006 (initiated Feb 1, 2006) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |