FDA Medical Device Recalls (openFDA)
Medtronic Navigation, Inc: AxiEM EM Knee Kit, and associated workstation.
- Recall number
- Z-0718-06
- Recalling firm
- Medtronic Navigation, Inc
- Product
- AxiEM EM Knee Kit, and associated workstation.
- Status
- Terminated
- Initiated
- 2006-02-01
- Posted
- 2006-04-07
- Terminated
- 2006-04-06
- 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.
- Lot, serial or model codes
- Catalog Number: 9732140. Lot numbers 2005100642 and 2005100645.
- 510(k) numbers
- ["K001284","K043088"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 1000517638
- Firm city
- Louisville
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28