| Class 2 Device Recall CD Horizon Agile dynamic stabilization device | |
Date Initiated by Firm | November 12, 2007 |
Date Posted | September 11, 2008 |
Recall Status1 |
Terminated 3 on August 10, 2010 |
Recall Number | Z-1417-2008 |
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 7901500, 15mm, 5.5mm dia x 100mm, size: 15mm x 100mm, for spinal fixation. |
Code Information |
ALL CODES |
Recalling Firm/ Manufacturer |
Medtronic Sofamor Danek USA Inc 1800 Pyramid Place Memphis TN 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 | 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 | 105 units |
Distribution | Worldwide Distribution: USA, Canada, India, Venezuela, Netherlands, Chile, Brazil, and Australia. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = NQP
|
|
|
|