FDA-Device2022-03-09Class II
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Orthosoft, Inc. dba Zimmer CAS
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.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AR, NY, OH, TN, TX and the countries of Canada and the Netherlands.
Affected count
14 units US; 132 units OUS
Manufactured in
3300-75 Queen St, Montreal, Canada
Products
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0721-2022Don't want to check this manually?
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