Events

Recall of Synthes Kirschner Wire

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

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
    19552
  • Event Initiated Date
    2015-12-10
  • 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: Johnson & Johnson (NZ) Limited, 13a Gabador Place, Mt Wellington, AUCKLAND
  • Reason
    The kirschner wire is made from co35ni35cr20mo10 (mp35n) which is cobalt based alloy containing 35% nickel. however, the label and technique guide incorrectly indicate that the devices are made of stainless steel., the product is shipped with an insert which references the potential risk of allergy/hypersensitivity reactions, but there is no specific information on the label or in the technique guide with regards to the percentage of nickel content in the devices., please note: - product shipped in "kits" in new zealand are not in packaging and therefore not labelled.
  • Action
    Manufacturer to issue advice regarding use

Device

Synthes Kirschner Wire
  • Model / Serial
    Model: Part No: 02.113.001, Affected: All Lot numbers
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH