Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901040, 10mm, 5.5mm dia x
FDA device recall Z-1411-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Reason for recall
- Breaks: Shear failure of the cable component of the system.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NQP
- Quantity affected
- 631 units
- Distribution
- Worldwide Distribution: USA, Canada, India, Venezuela, Netherlands, Chile, Brazil, and Australia.
- Date initiated
- 2007-11-12
- Date posted
- 2008-09-11
- Date terminated
- 2010-08-10
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CD HORIZON SPINAL SYSTEM (K060615) | Medtronic Sofamor Danek | 2006-10-25 |