Device recall
Z-1694-2009: Capless Li Pedicle Screw System, Diameters - 4.75mm, 5.5mm, 6.5mm, 7.5mm…
FDA device recall · Class II · X Spine Systems Inc
Key facts
| Recall number (Z-number) | Z-1694-2009 |
|---|---|
| Recall event | 51956 |
| Product | Capless Li Pedicle Screw System, Diameters - 4.75mm, 5.5mm, 6.5mm, 7.5mm, 8.25mm, Lengths 30mm-55mm, labeled non-sterile. The Capless LI Pedicle Screw System is indicated for the treatment of sever spondylolisthesis of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous… |
| Product code | MNH |
| Recalling firm | X Spine Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 25, 2012 |
| 510(k) numbers | K072282 |
| 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