BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0721-2022 · Reported March 9, 2022

    Enforcement

    Recall Number
    Z-0721-2022
    Event ID
    89619
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Orthosoft, Inc. dba Zimmer CAS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 9, 2022
    Initiation Date
    January 7, 2022
    Classification Date
    March 3, 2022
    Address
    3300-75 Queen St, Montreal, N/A, Canada

    Description

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

    Reason

    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.

    Code Info

    Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1

    Distribution

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

    Quantity

    14 units US; 132 units OUS