Device recall
Z-2197-2011: Manta Ray" Anterior Cervical Plate (ACP) System, Intended use: The Manta Ray ACP…
FDA device recall · Class II · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-2197-2011 |
|---|---|
| Recall event | 58167 |
| Product | Manta Ray" Anterior Cervical Plate (ACP) System, Intended use: The Manta Ray ACP System is an anterior cervical plate that is indicated for temporary stabilization of the cervical spine from C2-C7. |
| Product code | KWQ |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 27, 2011 |
| 510(k) numbers | K080690 |
| FEI number | 3003418325 |
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