Device recall
Z-0855-2014: Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver…
FDA device recall · Class II · Orthofix, Inc.
Key facts
| Recall number (Z-number) | Z-0855-2014 |
|---|---|
| Recall event | 66969 |
| Product | Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument. |
| Product code | KWP |
| Recalling firm | Orthofix, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 9, 2014 |
| 510(k) numbers | K081684 |
| 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