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U.S. Department of Health and Human Services

Class 2 Device Recall CD Horizon Agile dynamic stabilization device

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 Class 2 Device Recall CD Horizon Agile dynamic stabilization device see related information
Date Posted September 11, 2008
Recall Status1 Terminated on August 10, 2010
Recall Number Z-1408-2008
Recall Event ID 46735
510(K)Number K060615 
Product Classification spinal fixation device - Product Code NQP
Product Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901000, 10mm, 5.5mm dia x 100mm, size: 10mm x 100mm, for spinal fixation.
Code Information ALL LOTS
Recalling Firm/
Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis TN 38132-1719
For Additional Information Contact Bert Kelly
Manufacturer Reason
for Recall
Breaks: Shear failure of the cable component of the system.
FDA Determined
Cause 2
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 231 units
Distribution Worldwide Distribution: USA, Canada, India, Venezuela, Netherlands, Chile, Brazil, and Australia.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NQP and Original Applicant = MEDTRONIC SOFAMOR DANEK