Device recall
Z-1608-2011: ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction…
FDA device recall · Class II · Orthofix Inc
Key facts
| Recall number (Z-number) | Z-1608-2011 |
|---|---|
| Recall event | 57211 |
| Product | ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Part #68-0111, Lot #16518-LC18. Intended for use in conjunction with Multi-Axial Reduction Screw Assemblies. During assembly of a construct, the Anti-Splay Cap locks onto the Screw Body to prevent the Screw Body… |
| Product code | NKB |
| Recalling firm | Orthofix Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 25, 2011 |
| 510(k) numbers | K081684 |
| FEI number | 2183449 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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