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U.S. Department of Health and Human Services

Class 3 Device Recall Knee navigation trackers.

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  Class 3 Device Recall Knee navigation trackers. see related information
Date Initiated by Firm February 01, 2006
Date Posted April 07, 2006
Recall Status1 Terminated 3 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/
Medtronic Navigation, Inc
826 Coal Creek Circle
Louisville CO 80027-9710
For Additional Information Contact
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 2
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