Device recall
Z-3127-2017: Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334…
FDA device recall · Class II · Orthofix, Inc
Key facts
| Recall number (Z-number) | Z-3127-2017 |
|---|---|
| Recall event | 77882 |
| Product | Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone screw in order to provide clearance to allow for proper seating of the modular body, as well as to… |
| Product code | NKB |
| Recalling firm | Orthofix, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 4, 2018 |
| 510(k) numbers | K171082 |
| 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