Recall of Stryker Neptune 2 Ultra Waste Management System

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

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
    14358
  • Event Initiated Date
    2013-05-31
  • Event Country
  • Event Source
    NZMMDSA
  • Event Source URL
  • 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: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Reason
    Following reports of a patient death and injury reports associated with this device, stryker had developed new warnings and labelling to be affixed to the neptune 1 silver and the neptune 2 ultra to remind customers of the steps they need to take to continue using these devices. additional user training is also being provided.
  • Action
    Instructions for use to be updated

Device

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    NZMMDSA