BEUDAMED
    FDA Enforcement Class II Terminated

    Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box

    Recall: Z-2475-2020 · Reported July 8, 2020

    Enforcement

    Recall Number
    Z-2475-2020
    Event ID
    85884
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mueller Sports Medicine, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 8, 2020
    Initiation Date
    June 18, 2020
    Classification Date
    June 30, 2020
    Termination Date
    October 29, 2021
    Address
    1 Quench Dr, N/A, Prairie Du Sac, WI, 53578-2100, United States

    Description

    Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box

    Reason

    Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex".

    Code Info

    Reference number: 64217, UPC number: 074676642178

    Distribution

    U.S. distribution only: AR and OH.

    Quantity

    135,354 units