BEUDAMED
    FDA Recall Terminated

    Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely for lower limb prosthetic fittings.

    Recall: Z-2438-2015 · Initiated August 12, 2015

    Recall

    Recall Number
    Z-2438-2015
    Event Number
    71950
    Firm
    Otto Bock Healthcare Product Brehmstrasse
    FEI Number
    3005190268
    Product Code
    ISW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 12, 2015
    Posted
    August 21, 2015
    Terminated
    October 28, 2015
    Address
    16 Wien Austria

    Description

    Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely for lower limb prosthetic fittings.

    Reason

    Otto Bock Healthcare Products GmbH is recalling the new Genium X3 knee joint prosthesis due to issues with the resistance-control of the hydraulics, which may fail under conditions.

    Action

    The consignee was notified via e-mail and telephone on 12 August 2015. The affected product was identified, as well as the reason for the recall. The firm will replace the affected device with a new one. A return authorization and label will be provided for the recalled product to be returned as soon as possible.

    Distribution

    Distributed to the state OH.

    Quantity

    1