# FDA recall Z-0475-2021

> **Conformis, Inc.** · Class II · device recall initiated 2020-09-21.

## 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.

## Distribution

US Distribution in CA.

## Key facts

- **Recall number:** Z-0475-2021
- **Recalling firm:** Conformis, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-21
- **Report date:** 2020-12-02
- **Termination date:** 2023-06-12

- **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-0475-2021

## Citation

> AI Analytics. FDA recall Z-0475-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0475-2021. Source: US FDA. Licensed CC0.

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