Class II — Cochlear Americas Inc.
| Recalling firm | COCHLEAR AMERICAS |
|---|---|
| Registered facility | View this company's 7 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed. |
| Product | Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes |
| Quantity | 26 |
| Distribution | US Nationwide Distribution to CO, OH, OR, MI, and CA. |
| Initiated | 2015-06-05 |
| Classified | 2015-07-20 |
| Terminated | 2015-08-05 |
| Recall number | Z-2155-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cochlear Americas Inc. (Z-2155-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71509/
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