Recall Z-1424-2008 ยท NQP Posterior Metal/Polymer Spinal System, Fusion
Medtronic Sofamor Danek USA Inc
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901590, 15mm, 5.5mm dia x 90mm, size: 15mm x 90mm, for spinal fixation.
| Date | Sep 11, 2008 (initiated Nov 12, 2007) |
| Status | Terminated |
| 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 | 183 units |
| Distribution | Worldwide Distribution: USA, Canada, India, Venezuela, Netherlands, Chile, Brazil, and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060615 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Oct 25, 2006 |