Class II — Potential Health Hazard

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

ConForMIS Unicondylar Knee Replacement System iUNI G2 Recalled by ConforMIS, Inc. Due to May contain small amounts of ethylene glycol residue

Date: August 31, 2015
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

ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M57220600210(US) M5722INT0600210 (OUS)

Quantity: 71 units

Why Was This Recalled?

May contain small amounts of ethylene glycol residue

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)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