FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881510, 15mm, 5.5mm dia x 110mm, size: 15mm x 110mm, not for distribution in the U.S.A. or its territories, for spinal fixation.
- Recall number
- Z-1434-2008
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Product
- Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881510, 15mm, 5.5mm dia x 110mm, size: 15mm x 110mm, not for distribution in the U.S.A. or its territories, for spinal fixation.
- Status
- Terminated
- Initiated
- 2007-11-12
- Posted
- 2008-09-11
- Terminated
- 2010-08-10
- Reason
- Breaks: Shear failure of the cable component of the system.
- Root cause
- Device Design
- Action
- Medtronic Sofamor Danek initiated its recall on 12/12/2007 by letter to all Risk Managers who received the product at their hospital. Letter were also mailed to surgeons who have implanted the product. Sales Representatives were notified via a conference call and letter to follow-up with thier respective surgeons who have implanted the product to verify that their surgeon received the communication of the recall and that they are aware that patient monitoring is recommended.
- Quantity
- 47 units
- Distribution
- Worldwide Distribution: USA, Canada, India, Venezuela, Netherlands, Chile, Brazil, and Australia.
- Lot, serial or model codes
- ALL CODES
- 510(k) numbers
- ["K060615"]
- PMA numbers
- not on file
- Product code
- NQP
- 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