Device recall
Z-1512-2015: Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device…
FDA device recall · Class II · X Spine Systems Inc
Key facts
| Recall number (Z-number) | Z-1512-2015 |
|---|---|
| Recall event | 70774 |
| Product | Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies. |
| Product code | MNH |
| Recalling firm | X Spine Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 21, 2015 |
| 510(k) numbers | K120832 |
| FEI number | 3005031160 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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