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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 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-1411-2008
Recall Event ID 46735
Premarket Notification
510(K) Number
K060615 
Product Classification Posterior Metal/Polymer Spinal System, Fusion - Product Code NQP
Product Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901040, 10mm, 5.5mm dia x 40mm, size: 10mm x 40mm, for spinal fixation.
Code Information ALL CODES
Recalling Firm/
Manufacturer
Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis, Tennessee 38132-1719
For Additional Information Contact Bert Kelly
901-396-1800
Manufacturer Reason
for Recall
Breaks: Shear failure of the cable component of the system.
FDA Determined
Cause 2
DESIGN: 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 631 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
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