Device recall
Z-0203-2016: MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate…
FDA device recall · Class II · Biomet Spine, LLC
Key facts
| Recall number (Z-number) | Z-0203-2016 |
|---|---|
| Recall event | 72312 |
| Product | MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization. |
| Product code | KWQ |
| Recalling firm | Biomet Spine, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 29, 2016 |
| 510(k) numbers | K080646, K133518 |
| FEI number | 3012447612 |
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