Events

Recall of Synthes Cortex Screw

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
    20109
  • Event Initiated Date
    2016-05-02
  • 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: Johnson & Johnson (NZ) Limited, 13a Gabador Place, Mt Wellington, AUCKLAND
  • Reason
    Specific part and lot of the 4.5mm cortex screws, length 20mm may contain a 4.5mm cortex screw that s 22mm in length. the screws are both etched and labelled with the 20mm part numbers., the outside package labelling and the etching on the product would indicate to the user that the screw is 2mm shorter than its actual length of 22mm., the potential harm of damage to surrounding structures ,including damage to articular surface during insertion, could occur depending upon the location and angle of screw.
  • Action
    Product to be returned to supplier

Device

Synthes Cortex Screw
  • Model / Serial
    Model: 414.82, Affected: 2610310
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH