Events

Recall of Orthofix Intramedullary Skeletal Kinetic Distractor (ISKD)

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

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
    13332
  • Event Initiated Date
    2012-08-22
  • 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
    There is a possibility that the iskd limb lengthener may stop distracting post-operatively during treatment, which may result in premature bone consolidation (limb not achieving the desired length) leading to revision surgery to remove and/or replace the device.
  • Action
    Product to be returned to supplier

Device

Orthofix Intramedullary Skeletal Kinetic Distractor (ISKD)
  • Model / Serial
    Model: 33 models, Affected: All serial numbers
  • Manufacturer
    Orthofix Srl

Manufacturer

Orthofix Srl