Device recall
Z-0411-2007: Rocker Reducer, part of the SiLo Spinal System, REF 8880014, Rx only, Material…
FDA device recall · Class II · Medtronic Sofamor Danek Instrument Manufacturing
Key facts
| Recall number (Z-number) | Z-0411-2007 |
|---|---|
| Recall event | 37066 |
| Product | Rocker Reducer, part of the SiLo Spinal System, REF 8880014, Rx only, Material: Stainless Steel, qty: 1 ea, non-sterile, Medtronic Sofamor Danek, 1800 Pyramid Place Memphis, TN 38132, USA, Manufactured at: Bartlett, Tennessee, USA |
| Product code | MNI |
| Recalling firm | Medtronic Sofamor Danek Instrument Manufacturing |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 16, 2007 |
| 510(k) numbers | K042210 |
| FEI number | 3004564008 |
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