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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

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Event Detail

Event ID 63722
Product Type Devices
Status Ongoing
Recalling Firm Medtronic Navigation, Inc.
City Louisville
State CO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-13
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution--US (nationwide) including the states of CA, FL, MA, LA, and MI and the countries of Switzerland, Saudi Arabia, Lebanon, Canada and Korea.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. The device is reusable and requires sterilization according to product labeling. . Lot number 120203. Class II Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation System due to a defect related to the internal threading for component set up. 12 Units Z-0441-2013