Events

Recall of Anspach 16cm Minimally Invasive Attachment

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

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
    14720
  • Event Initiated Date
    2013-05-24
  • 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: Synthes New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, Auckland 1060
  • Reason
    During hydrogen peroxide sterilization testing of the mia16 device it was determined that the sterrad 100s is not capable of achieving the expected sterility assurance level (sal) of 10-6. since the mia25t is longer and has a smaller lumen than the mia16, the mia25t is also affected. therefore, sterrad 100s should not be used on the mia16 or mia25t attachment.
  • Action
    Instructions for use to be updated

Device

Anspach 16cm Minimally Invasive Attachment

Manufacturer

Anspach Effort Inc