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.
This recall has been terminated (originally issued October 26, 2010).
- Company
- Medtronic Navigation, Inc.
- Recall Initiated
- September 24, 2010
- Posted
- October 26, 2010
- Terminated
- April 13, 2011
- Recall Number
- Z-0145-2011
- Quantity
- 8 units
- Firm Location
- Louisville, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Drill guide handle may detach unintentionally during use.
Distribution
Worldwide distribution: USA including states of DC, IN, PA, and VA and country of Japan.
Lot / Code Info
Lot number 100526
Root Cause
Other
Action Taken
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 that is correctly manufactured. For further information or if you have questions regarding use of the Vertex Max Drill Guide, please contact Medtronic Navigation Technical Services at 1-800-595-9709.