Recall Z-1042-2011 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc
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.
| Date | Feb 4, 2011 (initiated Dec 15, 2010) |
| Status | Terminated |
| Reason | Incorrectly manufactured drill tube could cause incorrect screw placement during spinal surgery. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050438 | STEALTHSTATION SYSTEM UPDATE Medtronic Surgical Navigation Technologies, Jun 2, 2005 |