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 Posterior Stabilized (PS) Knee Replacement System Recalled by Conformis, Inc. Due to The labeling of the boxes and sterile pouches...

Date: January 4, 2019
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 Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102

Quantity: 2

Why Was This Recalled?

The labeling of the boxes and sterile pouches did not match the contents.

Where Was This Sold?

This product was distributed to 1 state: NH

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