iTotal Hip Replacement System — Class II medical device recall Z-0475-2021
Terminated recall by Conformis, Inc., reported 2020-12-02, distributed in CA. Incorrect hip components were provided in kits.
| Recall number | Z-0475-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Conformis, Inc., Billerica, MA, United States |
| Recall initiated | 2020-09-21 |
| Classified | 2020-11-20 |
| Reported by FDA | 2020-12-02 |
| Terminated | 2023-06-12 |
| Distributed | CA |
| Quantity | 2 |
| Serial numbers | 0469255 |
| Model numbers | HAA-050-D020-020102 |
Product
iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.
Reason for recall
Incorrect hip components were provided in kits.
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-0475-2021. 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.