AxiEM EM Knee Kit, and associated workstation recallZ-0718-06 · Medtronic Navigation, Inc · initiated Feb 1, 2006
Terminated All recalls posted in April 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Navigation, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Other
What the company is doing
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
Recall details
- Recall number
- Z-0718-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 1, 2006
- Posted by the FDA
- Apr 7, 2006
- Recalling firm
- Medtronic Navigation, Inc
- Quantity
- 84 kits
- Product code
- HAW
- FDA submissions
- K001284, K043088
- 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 description
AxiEM EM Knee Kit, and associated workstation.
Code information (models, lots, serial numbers)
Catalog Number: 9732140. Lot numbers 2005100642 and 2005100645.
Other devices under the same FDA submission
23 devices cleared under K001284, K043088 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Fusion™ ENT Image Guidance System 9733560XOMMedtronic Navigation, Inc. · Neurological stereotaxic Instrument1,316 reports
- Fusion™ ENT Image Guidance System 9733560Medtronic Navigation, Inc. · Neurological stereotaxic Instrument458 reports
- Fusion™ ENT Image Guidance System 9733560XOMMedtronic Navigation, Inc. · Neurological stereotaxic Instrument188 reports
- Fusion™ ENT Image Guidance System 9733560XOMRMedtronic Navigation, Inc. · Neurological stereotaxic Instrument66 reports
- AXIEM™ 9733300Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- AXIEM™ 9731975Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- N/A 9733449Medtronic Navigation, Inc. · Neurological stereotaxic Instrument40 reports
- AxiEM™ 9733533XOMMedtronic Navigation, Inc. · Neurological stereotaxic Instrument24 reports
- N/A 9733450Medtronic Navigation, Inc. · Neurological stereotaxic Instrument16 reports
- N/A 9733533XOMMedtronic Navigation, Inc. · Neurological stereotaxic Instrument8 reports
- N/A 9733533Medtronic Navigation, Inc. · Neurological stereotaxic Instrument7 reports
- N/A 9733448Medtronic Navigation, Inc. · Neurological stereotaxic Instrument5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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