Device recall
Z-2136-2014: Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex…
FDA device recall · Class II · X Spine Systems Inc
Key facts
| Recall number (Z-number) | Z-2136-2014 |
|---|---|
| Recall event | 68863 |
| Product | Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery. |
| Product code | FZX |
| Recalling firm | X Spine Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 14, 2014 |
| FEI number | 3005031160 |
At a glance
- None 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