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 iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111 Recalled by ConforMIS, Inc. Due to Incorrect femoral component distributed

Date: January 28, 2016
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 iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111

Quantity: 1 unit

Why Was This Recalled?

Incorrect femoral component distributed

Where Was This Sold?

This product was distributed to 1 state: KY

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