iTotal Hip Replacement System — Class II medical device recall Z-0731-2019
Terminated recall by Conformis, Inc., reported 2019-01-23, distributed in TN. The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interfe
| Recall number | Z-0731-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Conformis, Inc., Billerica, MA, United States |
| Recall initiated | 2018-10-16 |
| Classified | 2019-01-11 |
| Reported by FDA | 2019-01-23 |
| Terminated | 2020-06-29 |
| Distributed | TN |
| Quantity | 1 |
| Serial numbers | 0424647 |
| Model numbers | HAA-050-D001-020101 |
Product
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Reason for recall
The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.
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-0731-2019. 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.