FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek Extended Length Trocar, Size : L=50MM, Item No.: 7578014, Mat'l: Stainless Steel, non-sterile, Rx only, Trocars used with the CD HORIZON LEGACY" Percutaneous Peek Spinal System
- Recall number
- Z-0607-2010
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Product
- Medtronic Sofamor Danek Extended Length Trocar, Size : L=50MM, Item No.: 7578014, Mat'l: Stainless Steel, non-sterile, Rx only, Trocars used with the CD HORIZON LEGACY" Percutaneous Peek Spinal System
- Status
- Terminated
- Initiated
- 2009-12-07
- Posted
- 2010-01-12
- Terminated
- 2011-01-14
- Reason
- The Trocar may not fully engage with the Rod Inserter or may prematurely disengage.
- Root cause
- Device Design
- Action
- On 12/7/2009, the Sales Representatives were notified by conference call and email regarding the recall. The recall notices were mailed directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included respectively, on 12/09/2009 with a delivery date of 12/10/09.
- Quantity
- 266
- Distribution
- Nationwide distribution, and the Netherlands
- Lot, serial or model codes
- All Codes
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1000477302
- Firm city
- Memphis
- Firm state
- TN
- 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