# FDA recall Z-1775-2019

> **Conformis, Inc.** · Class II · device recall initiated 2019-03-29.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-1775-2019
- **Recalling firm:** Conformis, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-29
- **Report date:** 2019-06-19
- **Termination date:** 2020-04-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Billerica, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1775-2019

## Citation

> AI Analytics. FDA recall Z-1775-2019. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1775-2019. Source: US FDA. Licensed CC0.

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