iTotal Hip Replacement System — Class II medical device recall Z-0064-2020
Terminated recall by Conformis, Inc., reported 2019-10-16, distributed in MD, NV. Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
| Recall number | Z-0064-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Conformis, Inc., Billerica, MA, United States |
| Recall initiated | 2019-08-22 |
| Classified | 2019-10-08 |
| Reported by FDA | 2019-10-16 |
| Terminated | 2020-07-08 |
| Distributed | MD, NV |
| Quantity | 1 |
| Model numbers | HBS-033-0013-020101 |
Product
iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
Reason for recall
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
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-0064-2020. 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.