BEUDAMED
    FDA Enforcement Class II Terminated

    21Y14 PushValve 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-0826-2019 · Reported February 20, 2019

    Enforcement

    Recall Number
    Z-0826-2019
    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 PushValve 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

    538 units