Device recall
Z-1089-2014: Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade…
FDA device recall · Class II · Orthofix, Inc
Key facts
| Recall number (Z-number) | Z-1089-2014 |
|---|---|
| Recall event | 66660 |
| Product | Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and is indicated for: A. Degenerative disc… |
| Product code | KWQ |
| Recalling firm | Orthofix, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 9, 2014 |
| 510(k) numbers | K130825 |
| 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