Events

Recall of Otto Bock 4R82 Tube Clamp Adapter

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Otto Bock Healthcare GmbH.

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
    13187
  • Event Initiated Date
    2012-07-23
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Ottobock Australia Pty, Suite 1.01 Century Corporate Centre, 62 Norwest Boulevarde, Baulkham Hills, NSW 2153, AUSTRALIA
  • Reason
    The manufacturer received some complaints about adapters that show a crack starting at the clamping of the adapter into direction of the clamping slot. due to the crack, the clamping to the tube adapter is lost and the prosthesis twists when loaded. depending on the situation this may cause the patient to fall.
  • Action
    Product to be returned to supplier

Device

Otto Bock 4R82 Tube Clamp Adapter

Manufacturer

Otto Bock Healthcare GmbH