Class 2 Device Recall Treatment Guidance Platform

• Date Initiated by Firm: October 31, 2003
• Date Posted: December 17, 2003
• Recall Status: Terminated 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/ Manufacturer: 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: Other
• 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