Events

Recall of Synthes T-PAL Applicator Instrument, technique guide

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
    17094
  • Event Initiated Date
    2014-08-05
  • 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 t-pal technique guide has been updated to clarity the instrument handling of the t-pal applicator.
  • Action
    Instructions for use to be updated

Device

Synthes T-PAL Applicator Instrument, technique guide
  • Model / Serial
    Model: Part Number: 036.001.088, Affected: Versions up to and including AC
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH