Recall Z-0145-2011 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc
Vertex Max Drill Guide, Catalog Number 9732355, to be used with a Medtronic Computer-Assisted Surgery System to help assist with screw placement during spine procedures. To be used with a Medtronic Computer-Assisted Surgery System to help assist with screw placement during spine procedures.
| Date | Oct 26, 2010 (initiated Sep 24, 2010) |
| Status | Terminated |
| Reason | Drill guide handle may detach unintentionally during use. |
| Root cause | Other |
| Action | Medtronic Navigation sent a "Product Correction Notification" letter dated September 22, 2010 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to set aside and do not use the Vertex Max Drill Guide 9732355, Lot Number 100526 and complete and return the Verification of Field Action Completion form via email: steve.murray@medtronic.com or fax: 720-890-3517. A Medtronic representative will contact the customer, visit their facility, remove the defective product, and provide a replacement Vertex Max Drill Guide t |
| Quantity | 8 units |
| Distribution | Worldwide distribution: USA including states of DC, IN, PA, and VA and country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050438 | STEALTHSTATION SYSTEM UPDATE Medtronic Surgical Navigation Technologies, Jun 2, 2005 |