Events

Recall of Kryptonite Bone Cement / X-Radiopaque Bone Cement

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Doctors Research Group 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
    13669
  • Event Initiated Date
    2012-11-07
  • 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: CARSL Consulting, 50B Puketapu Road, Taradale, Napier 4112
  • Reason
    Several recent modifications have been made to the instructions for use including updates to product warnings and storage requirements., 4 surgeons contacted on 24 and 25th october 2012.
  • Action
    Instructions for use to be updated

Device

Kryptonite Bone Cement / X-Radiopaque Bone Cement
  • Model / Serial
    Model: KRYP-Z-10, KRYP-Z-05, Affected: All serial numbers and lot numbers produced within the last 18 months
  • Manufacturer
    Doctors Research Group Inc

Manufacturer

Doctors Research Group Inc
  • Source
    NZMMDSA