Device recall
Z-2590-2018: Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes…
FDA device recall · Class II · Envoy Medical Corporation
Key facts
| Recall number (Z-number) | Z-2590-2018 |
|---|---|
| Recall event | 80489 |
| Product | Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable Middle Ear Hearing Device. |
| Product code | OAF |
| Recalling firm | Envoy Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 3, 2020 |
| PMA numbers | P090018 |
| FEI number | 3004007782 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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