AxiEM EM Knee Kit, and associated workstation.
FDA device recall Z-0718-06 · posted 2006-04-07 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc
- 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.
- Action taken
- 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
- Root cause
- Other
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 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.
- Date initiated
- 2006-02-01
- Date posted
- 2006-04-07
- Date terminated
- 2006-04-06
- Location
- Louisville, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE (K043088) | Medtronic Surgical Navigation Technologies | 2005-01-05 |
| STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM (K001284) | Medtronic Surgical Navigation Technologies | 2000-06-12 |