BEUDAMED
    FDA Enforcement Class II Terminated

    R82 by ETAC Push Brace for High-Low

    Recall: Z-0569-2022 · Reported February 16, 2022

    Enforcement

    Recall Number
    Z-0569-2022
    Event ID
    89236
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    R82 A/S
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 16, 2022
    Initiation Date
    December 8, 2021
    Classification Date
    February 8, 2022
    Termination Date
    September 5, 2023
    Address
    Parallelvej 3, N/A, Gedved, N/A, N/A, Denmark

    Description

    R82 by ETAC Push Brace for High-Low

    Reason

    The chrome surface of the push brace can crack during use, potentially cutting the user.

    Code Info

    Model No. 8910545, Manufactured from 08/09/2021-10/03/2021

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of North Carolina and California and the countries of Czech Republic, Finland, Germany, Greece, Holland, Italy, Japan, Norway, Poland, Russia, Sweden, and United Kingdom.

    Quantity

    396 units