Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

iTotal Hip Replacement System Recalled by Conformis, Inc. Due to Incorrect hip components were provided in kits.

Date: September 21, 2020
Company: Conformis, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Conformis, Inc. directly.

Affected Products

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.

Quantity: 2

Why Was This Recalled?

Incorrect hip components were provided in kits.

Where Was This Sold?

This product was distributed to 1 state: CA

Affected (1 state)Not affected

About Conformis, Inc.

Conformis, Inc. has 16 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report