Device recall
Z-2136-2019: MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following…
FDA device recall · Class II · MED-EL Elektromedizinische Gereate, Gmbh
Key facts
| Recall number (Z-number) | Z-2136-2019 |
|---|---|
| Recall event | 81683 |
| Product | MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi1000 CONCERTO PIN +FLEXsoft; d. Mil000 CONCERTO +Standard; e. Mil000 CONCERTO +Medium; f. Mi1000 CONCERTO PIN +Standard; g. M11000 CONCERTO… |
| 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