Events

Recall of Rex Rehab

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Rex Bionics Limited.

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
    20156
  • Event Initiated Date
    2016-06-20
  • 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: Rex Bionics Limited, 58 Apollo Drive, Rosedale, Auckland 0751
  • Reason
    As part of the corrective and preventive action into an incident report, where a patient sustained an injury relating to incorrectly securing the heel stops on the rex, the sponsor has issued a recall for product correction to:, 1. reinforce the instructions in the current ifu around the importance of correct heel stop adjustment, and, 2. add an additional statement to the ifu to specifically highlight the use of external supports (such as braces, splints, supports) which may restrict a user's range of motion and cause serious harm.
  • Action
    Manufacturer to issue advice regarding use

Device

Rex Rehab

Manufacturer

Rex Bionics Limited
  • Source
    NZMMDSA