Events

Recall of Synthes Sternal ZipFix System

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
    15331
  • Event Initiated Date
    2013-09-04
  • 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 technique guide includes a precaution that the trigger must be released before and during cutting and that no cutting should take place under tension, however when using the 1st generation application instrument for sternal zipfix™ it is possible to cut the implant while the tensioning trigger is being squeezed (known as being cut under tension)., note: this issue applies to application instrument lots prior to 8100630 only (referred to as '1st generation' instruments).
  • Action
    Instructions for use to be updated

Device

Synthes Sternal ZipFix System
  • Model / Serial
    Model: Part Number: 03.501.080, Affected: Lot numbers prior to 8100630
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH