Device recall
Z-2283-2026: Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI…
FDA device recall · Class II · Advanced Bionics, LLC
Key facts
| Recall number (Z-number) | Z-2283-2026 |
|---|---|
| Recall event | 98916 |
| Product | Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals with severe-to-profound… |
| Product code | MCM |
| Recalling firm | Advanced Bionics, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P960058 |
| FEI number | 1000220815 |
At a glance
- None 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