Z-1412-2008

Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901045, 10mm...

Name: Z-1412-2008 Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901045, 10mm...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2007-11-12
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2007-11-12 / Terminated / root cause: design

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901045, 10mm, 5.5mm dia x 45mm, size: 10mm x 45mm, for spinal... on 2007-11-12. The reason FDA records is "Breaks: Shear failure of the cable component of the system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1412-2008
Status: Terminated
Initiated: 2007-11-12
Posted: 2008-09-11
Terminated: 2010-08-10
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901045, 10mm, 5.5mm dia x 45mm, size: 10mm x 45mm, for spinal fixation.
Product code: NQP Posterior Metal/Polymer Spinal System, Fusion
Reason for recall: Breaks: Shear failure of the cable component of the system.
Root cause tag: design
FDA 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 in commerce: 329 units
Distribution: Worldwide Distribution: USA, Canada, India, Venezuela, Netherlands, Chile, Brazil, and Australia.
Product codes and lots: ALL CODES

Product code NQP

K060615Class IICd Horizon Spinal SystemMedtronic Sofamor Danek / cleared 2006-10-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)