Device recall
Z-0891-2026: Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC…
FDA device recall · Class III · Orthofix U.S. LLC
Key facts
| Recall number (Z-number) | Z-0891-2026 |
|---|---|
| Recall event | 97862 |
| Product | Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel; 37-3107SP 12mm W X 12mm L, 7mm H, Parallel; 37-3108SP 12mm W X 12mm L, 8mm H, Parallel; 37-3109SP 12mm W X 12mm L, 9mm H, Parallel; 37-3110SP… |
| Product code | ODP |
| Recalling firm | Orthofix U.S. LLC |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K172437 |
| 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