FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1042-2011
- Recalling firm
- Medtronic Navigation, Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2010-12-15
- Posted
- 2011-02-04
- Terminated
- 2011-05-04
- 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.
- Lot, serial or model codes
- Lot number: 100721
- 510(k) numbers
- ["K050438"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 1000517638
- Firm city
- Louisville
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28