Device recall
Z-0464-2012: CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD…
FDA device recall · Class II · Medtronic Sofamor Danek USA Inc
Key facts
| Recall number (Z-number) | Z-0464-2012 |
|---|---|
| Recall event | 60568 |
| Product | CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X0809439, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 implantation |
| Product code | KWQ |
| Recalling firm | Medtronic Sofamor Danek USA Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 5, 2012 |
| 510(k) numbers | K042025 |
| FEI number | 1000477302 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database