Events

Recall of Synthes Reamer/Irrigator/Aspirator RIA Tube assembly 520mm

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
    17879
  • Event Initiated Date
    2014-12-17
  • 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 expiration date on the label for the referenced product is incorrect. existing testing supports an expiration date of 2 years from manufacturing. the affected products on the market were labelled with an expiration date of 10 years.
  • Action
    Product to be returned to supplier

Device

Synthes Reamer/Irrigator/Aspirator RIA Tube assembly 520mm
  • Model / Serial
    Model: Catalogue: 314.746S, Affected: Lots: 2251446, 2256902, 2256904, 2256906, 2261783, 2256903, 2256905, 2256907
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH