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 Identity Posterior Stabilised (PS) Knee Replacement System Model Number: Recalled by Conformis, Inc. Due to Incorrect tibial base plate implant packaged in kit

Date: February 22, 2022
Company: Conformis, Inc.
Status: Completed
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 Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101

Quantity: 1 unit

Why Was This Recalled?

Incorrect tibial base plate implant packaged in kit

Where Was This Sold?

This product was distributed to 1 state: MS

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