Events

Recall of Synthes Synream Guide Wire, 3.2mmm length 400mm

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
    16788
  • Event Initiated Date
    2014-06-04
  • 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
    The guide wire ø 3.2 mm, length 400 mm was mislabeled with an incorrect raw material. the label incorrectly declares molybdenum instead of wolfram and nickel as alloyed elements. the correct labelling is "cocrwni alloy".
  • Action
    Manufacturer to issue advice regarding use

Device

Synthes Synream Guide Wire, 3.2mmm length 400mm
  • Model / Serial
    Model: Part Number 357.399, Affected: Impacted Lots- 7569386; 7584396 and 7594057
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH