Device recall
Z-0966-2017: Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior…
FDA device recall · Class II · Amendia, Inc
Key facts
| Recall number (Z-number) | Z-0966-2017 |
|---|---|
| Recall event | 75857 |
| Product | Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1. |
| Product code | OVE |
| Recalling firm | Amendia, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 28, 2017 |
| 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