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U.S. Department of Health and Human Services

Class 2 Device Recall Vertex Max Drill Tube

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  Class 2 Device Recall Vertex Max Drill Tube see related information
Date Initiated by Firm December 15, 2010
Date Posted February 04, 2011
Recall Status1 Terminated 3 on May 04, 2011
Recall Number Z-1042-2011
Recall Event ID 57549
510(K)Number K050438  
Product Classification Neurological Stereotaxic Instrument - Product Code HAW
Product Vertex Max Drill Tube, Catalog Number 9733140, a component of the Navigated Vertex Max Drill Guide Kit, Catalog Number 9733370. Medtronic, Inc., Louisville, CO.

Used in conjunction with the StealthStation navigation systems to assist in screw placement during spine surgery.
Code Information Lot number: 100721
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc
826 Coal Creek Circle
Louisville CO 80027-9710
For Additional Information Contact
720-890-3217
Manufacturer Reason
for Recall		 Incorrectly manufactured drill tube could cause incorrect screw placement during spinal surgery.
FDA Determined
Cause 2		 Component design/selection
Action Consignees were notified by a Product Correction Notification letter on 12/15/2010 and given the affected product and a description of the problem. The letter stated that a Medtronic representative would contact customers to visit their facility and replace the affected guide with one that has been correctly manufactured. Additional information is available at 800-595-9709.
Quantity in Commerce 15 devices
Distribution Worldwide Distribution -- USA, including states of GA, IL, IN, MN, MO, OH, OR, PA, and TX and countries of Denmark, Finland, Singapore, Spain, and 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
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