Enforcement Report - Week of December 5, 2012
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Product Detail
| Product Description | 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. . |
|---|---|
| Recall Number | Z-0441-2013 |
| Classification | Class II |
| Code Info | Lot number 120203. |
| Product Distributed Qty | 12 Units |
| Reason For Recall | 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. |
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 | Letter |
| 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. |
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