Conformis iTotal Hip Replacement System: HBS-033-00xx-010101 — Class II medical device recall Z-1775-2019
Terminated recall by Conformis, Inc., reported 2019-06-19, distributed nationwide. Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths an
| Recall number | Z-1775-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Conformis, Inc., Billerica, MA, United States |
| Recall initiated | 2019-03-29 |
| Classified | 2019-06-13 |
| Reported by FDA | 2019-06-19 |
| Terminated | 2020-04-28 |
| Distributed | Nationwide (US) |
| Quantity | 128 |
| Serial numbers | 422796, 422797, 423231, 423398, 424244, 424392, 424450, 424510, 424647, 425276, 425346, 425418, 425455, 425456, 425607, 425608, 425755, 425866, 426034, 426069, 426118, 426297, 426309, 426382, 427186 and 109 more |
Product
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
Reason for recall
Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
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-1775-2019. 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.