Events

Recall of Mizuho OSI Orthopaedic Table Top Spar

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

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
    14124
  • Event Initiated Date
    2013-01-24
  • 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: Surgico Medical & Sugical Ltd, Unit A, 3 Whetu Place, Rosedale, North Shore City, AUCKLAND 0632
  • Reason
    The manufacturer advises there is potential for the de-lamination of the epoxy bond between the 5855-901 orthopedic table spar's aluminum insert and the carbon fiber spar itself. if the epoxy bond fails the aluminum plug may migrate out of the carbon fiber tube.
  • Action
    Product to be modified

Device

Mizuho OSI Orthopaedic Table Top Spar
  • Model / Serial
    Model: Model: 5855-901, Affected: Manufactured between Jan 1996 and Dec 2007
  • Manufacturer
    Mizuho OSI

Manufacturer

Mizuho OSI