Conformis, Inc. recalls iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (…

Recall date

December 3, 2018

Source

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

Recall number

Z-1108-2019

FDA classification

Class II

Brand / firm

Conformis, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.

Why it was recalled

The kits were prepared with incorrect patient ID labels and may contain incorrect components.

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 Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) 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.