Device recall
Z-0894-2026: Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System…
FDA device recall · Class III · Orthofix U.S. LLC
Key facts
| Recall number (Z-number) | Z-0894-2026 |
|---|---|
| Recall event | 97862 |
| Product | Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number: 18-1025SP 11mm X 25mm FIREBIRD SI Screw; 18-1030SP 11mm X 30mm FIREBIRD SI Screw; 18-1035SP 11mm X 35mm FIREBIRD SI Screw; 18-1040SP 11mm X 40mm FIREBIRD SI Screw; 18-1045SP 11mm X 45mm FIREBIRD SI… |
| Product code | OUR |
| Recalling firm | Orthofix U.S. LLC |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K200696 |
| FEI number | 2183449 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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