FDA recall Z-0721-2022

Orthosoft, Inc. dba Zimmer CAS · Class II · device

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2022-01-07
Report date: 2022-03-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Montreal, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0721-2022