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Orthosoft, Inc. dba Zimmer CAS recalls NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Recalled March 9, 2022 · FDA recall Z-0721-2022 · Orthosoft, Inc.
Hazard
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. · FDA Class II
Units
14 units US; 132 units OUS
Sold at
Worldwide distribution - US Nationwide distribution in the states of AR, NY, OH, TN, TX and the countries of Canada and the Netherlands.
Description
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.
Product
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Manufacturer(s)
Orthosoft, Inc. dba Zimmer CAS
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →