BEUDAMED
    FDA Enforcement Class II Terminated

    21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.

    Recall: Z-0827-2019 · Reported February 20, 2019

    Enforcement

    Recall Number
    Z-0827-2019
    Event ID
    81926
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ottobock Orthopedic Industrie
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 20, 2019
    Initiation Date
    January 10, 2019
    Classification Date
    February 13, 2019
    Termination Date
    June 22, 2021
    Address
    Max-Nader Str 15 D-37ns, N/A, Duderstadt, N/A, N/A, Germany

    Description

    21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.

    Reason

    Some of the installed valve-inserts have a diameter smaller than the specification.

    Code Info

    The products with an article number listed below and delivered between May 1, 2017 and January 19, 2018

    Distribution

    US Nationwide Distribution

    Quantity

    1 unit