Events

Recall of Stryker Neptune 2 Rover Surgical fluid/smoke 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
    18723
  • Event Initiated Date
    2015-07-06
  • 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: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Reason
    It has been identified during the installation of neptune rovers, there is a potential for the rover's diverter valve assembly to not actuate during docking, preventing the cleaning cycle from occurring and inhibiting prefill water from being supplied to the neptune fresh water system. the diverter valve's material combined with the heat-treating process has the potential to cause diverter valve corrosion when the rover is allowed to sit for a period of greater than 40 days., only neptune 2 rovers out of use for greater than 40 days have the potential of exhibiting the failure. neptune 2 rovers that have been used within the past 40 days are not likely to experience any issue.
  • Action
    Product to be modified

Device

Stryker Neptune 2 Rover Surgical fluid/smoke waste management system
  • Model / Serial
    Model: 0702-002-000, Affected: Serial Numbers ranging from 0803118093 through 1505400223
  • Manufacturer
    Stryker Instruments

Manufacturer

Stryker Instruments
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NZMMDSA