Device recall
Z-0316-2018: Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling…
FDA device recall · Class II · Amendia, Inc
Key facts
| Recall number (Z-number) | Z-0316-2018 |
|---|---|
| Recall event | 77986 |
| Product | Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System. |
| Product code | OVE |
| Recalling firm | Amendia, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 15, 2019 |
| 510(k) numbers | K152972 |
| FEI number | 3007970248 |
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