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U.S. Department of Health and Human Services

Class 2 Device Recall Treatment Guidance Platform

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  Class 2 Device Recall Treatment Guidance Platform see related information
Date Initiated by Firm October 31, 2003
Date Posted December 17, 2003
Recall Status1 Terminated 3 on December 19, 2003
Recall Number Z-0231-04
Recall Event ID 27734
510(K)Number K001153  K021980  K012937  K030552  
Product Classification Neurological Stereotaxic Instrument - Product Code HAW
Product Fix pins associated with Stealth Station Treatment Guidance Platform
Code Information 3'' fix pin - 9730476, Lot numbers 200302130552, 200302140566 and 200302260619.  5'' fix pin - 9730477, Lot numbers200302140564, and 200303030641.
Recalling Firm/
Medtronic Surgical Navigation Tech, Inc
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information Contact
720-890 Ext. 3200
Manufacturer Reason
for Recall
Surgical devices intended for single use were not labeled for single use.
FDA Determined
Cause 2
Action Consignees were notified by letter on 11/01/2003.
Quantity in Commerce 127 devices
Distribution Domestic distribution to CA,FL,GA,KS,TX. Foreign distribution to Belgium, France, Germany, Hong Kong, Japan. No military or government consignees.
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
510(K)s with Product Code = HAW and Original Applicant = MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES