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.
FDA Recall Z-1042-2011 · Posted 2011-02-04
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Recalling FirmMedtronic Navigation, Inc
Recall StatusTerminated
Product CodeHAW
Date Initiated2010-12-15
Date Terminated2011-05-04
Product Quantity15 devices
Reason for Recall
Incorrectly manufactured drill tube could cause incorrect screw placement during spinal surgery.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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