Class 3 Device Recall Knee navigation trackers.

• Date Initiated by Firm: February 01, 2006
• Date Posted: April 07, 2006
• Recall Status: Terminated on April 06, 2006
• Recall Number: Z-0718-06
• Recall Event ID: 34604
• 510(K)Number: K043088 K001284
• Product Classification: Neurological Stereotaxic Instrument - Product Code HAW
• Product: AxiEM EM Knee Kit, and associated workstation.
• Code Information: Catalog Number: 9732140. Lot numbers 2005100642 and 2005100645.
• Recalling Firm/ Manufacturer: Medtronic Navigation, Inc; 826 Coal Creek Circle; Louisville CO 80027-9710
• For Additional Information Contact: 720-890-3325
• Manufacturer 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 Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HAW and Original Applicant = MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES