Herniatome — Class II medical device recall Z-0144-2022
Terminated recall by ADRIA SRL, reported 2021-10-27, distributed in NJ, NY. The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cy
| Recall number | Z-0144-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ADRIA SRL, San Giovanni In Persiceto, N/A, Italy |
| Recall initiated | 2021-05-17 |
| Classified | 2021-10-19 |
| Reported by FDA | 2021-10-27 |
| Terminated | 2023-11-06 |
| Distributed | NJ, NY |
| Lot numbers | AD0316/20 |
| Model numbers | 5091715 |
Product
Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715
Reason for recall
The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
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-0144-2022. 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.