Device recall
Z-0896-2026: Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti…
FDA device recall · Class III · Orthofix U.S. LLC
Key facts
| Recall number (Z-number) | Z-0896-2026 |
|---|---|
| Recall event | 97862 |
| Product | Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic… |
| Product code | ODP |
| Recalling firm | Orthofix U.S. LLC |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K203342 |
| FEI number | 2183449 |
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