Events

Recall of Synthese SynReam Medullary Reamer Head 8.5mm

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
    15579
  • Event Initiated Date
    2013-10-25
  • 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 possibility exists for intra-operative reamer head breakages which could result in un-retrieved device fragments of non-implant grade material to be left in the patient.
  • Action
    Product to be returned to supplier

Device

Synthese SynReam Medullary Reamer Head 8.5mm
  • Model / Serial
    Model: 352.085, Affected: 20290, 20292, 20713, 21025 and 24160
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH