Conformis, Inc. recalls iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement Sys…

Recall date

October 25, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0672-2020

FDA classification

Class II

Brand / firm

Conformis, Inc.

Sold / distributed

US Nationwide distribution in the state of GA.

Why it was recalled

Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.