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Class 3 Device Recall Knee navigation trackers. |
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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
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Product Classification |
Neurological Stereotaxic Instrument - Product Code HAW
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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
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For Additional Information Contact |
720-890-3325
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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.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = HAW and Original Applicant = MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
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