Cochlear Nucleus Sterile Silicone Template Product Usage: The… — Class II medical device recall Z-2155-2015
Terminated recall by Cochlear Americas Inc., reported 2015-07-29, distributed nationwide. Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expi
| Recall number | Z-2155-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cochlear Americas Inc., Centennial, CO, United States |
| Recall initiated | 2015-06-05 |
| Classified | 2015-07-20 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2015-08-05 |
| Distributed | Nationwide (US) |
| Quantity | 26 |
| Reason classes | sterility |
| Lot numbers | COH471122, COH471123 |
| Expiration dates | 2015-04-24, 2015-05-06 |
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
Reason for recall
Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2155-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.