Events

Recall of Stryker Sonopet Console

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

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
    14760
  • Event Initiated Date
    2013-06-06
  • 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
    Stryker has received several reports that the irrigation pump was not functioning. in the case where the irrigation pump fails, saline would not be provided to the tip. as a result the cooling function would be lost and could potentially cause the tip to heat up potentially resulting in tissue burns to the patient.
  • Action
    Product to be modified

Device

Stryker Sonopet Console
  • Model / Serial
    Model: Catalogue: 5450852000, Affected: Serial Numbers: 1134000114, 1134000124, 1134000134, 1134000144, 1134000184, 1134000204, 1209400174
  • Manufacturer
    Stryker Medtech K.K.

Manufacturer

Stryker Medtech K.K.
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NZMMDSA