Events

Recall of Genium X3

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Otto Bock Healthcare Product.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71950
  • Event Risk Class
    Class 2
  • Event Number
    Z-2438-2015
  • Event Initiated Date
    2015-08-12
  • Event Date Posted
    2015-08-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139437
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Assembly, knee/shank/ankle/foot, external - Product Code ISW
  • 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.

Device

Genium X3
  • Model / Serial
    Serial Number 201528049, manufactured on 01 July 2015
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to the state OH.
  • Product 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.
  • Manufacturer
    Otto Bock Healthcare Product

Manufacturer

Otto Bock Healthcare Product