BEUDAMED
    FDA Recall 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 · Initiated January 10, 2019

    Recall

    Recall Number
    Z-0826-2019
    Event Number
    81926
    Firm
    Ottobock Orthopedic Industrie Max-Nader Str 15 D-37ns Duderstadt Germany
    FEI Number
    3004024451
    Product Code
    ISY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 10, 2019
    Terminated
    June 22, 2021

    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.

    Action

    The firm initiated the recall by email on 01/10/2019 and followed with a letter on 01/11/2019. The letter identified the affected product, problem, actions to be taken and that a second letter with the replacement unit was forthcoming.

    Distribution

    US Nationwide Distribution

    Quantity

    538 units