Events

Recall of 3R62 Pheon Modular Knee Joint (External leg prosthesis)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Otto Bock Australia Pty Ltd.

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
    RC-2016-RN-01512-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-11-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01512-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    It has been found that the locking function may fail under certain conditions. the activation locking can only be activated by the clinician prior to the fitting of the device. the units that have been supplied in australia do not have the locking mechanism activated. please note that when the locking mechanism is set as non-active, the device poses no safety risk to the patient. however, it is possible that in the course of time the patient’s physical condition may require the locking function to be activated.
  • Action
    Otto Back is advising clinicians to contact patients who have been fitted with the affected device for a replacement with the new version.

Device

3R62 Pheon Modular Knee Joint (External leg prosthesis)
  • Model / Serial
    3R62 Pheon Modular Knee Joint (External leg prosthesis)Serial Numbers: 201447012, 201512056, 201517011ARTG Number: 113606
  • Manufacturer
    Otto Bock Australia Pty Ltd

Manufacturer

Otto Bock Australia Pty Ltd