Orthosoft, Inc. dba Zimmer CAS recalls NavitrackER Kit A: Knee, Model Number 20-8000-000-07,

Recall date

January 7, 2022

Source

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

Recall number

Z-0721-2022

FDA classification

Class II

Brand / firm

Orthosoft, Inc. dba Zimmer CAS

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of AR, NY, OH, TN, TX and the countries of Canada and the Netherlands.

Why it was recalled

The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention.

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

What was recalled

NavitrackER Kit A: Knee, Model Number 20-8000-000-07,