Device recall
Z-2137-2019: MED EL Cochlear Implant System, SONATATIi100, sold under the following implant…
FDA device recall · Class II · MED-EL Elektromedizinische Gereate, Gmbh
Key facts
| Recall number (Z-number) | Z-2137-2019 |
|---|---|
| Recall event | 81683 |
| Product | MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard Product Usage: The SONATATIi100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with… |
| Product code | PGQ |
| Recalling firm | MED-EL Elektromedizinische Gereate, Gmbh |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 22, 2020 |
| PMA numbers | P000025 |
| FEI number | 3000249315 |
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