Events

Recall of DF_Orthopaedic prosthesis implantation instrument, 13180

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by DePuy France SA.

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
    23088
  • Event Initiated Date
    2018-06-05
  • 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: Johnson & Johnson (NZ) Limited, 13a Gabador Place, Mt Wellington, AUCKLAND
  • Reason
    The manufacturer has identified the potential for debris/material to be found behind the o-rings for some corail neck trials.
  • Action
    Product to be modified

Device

DF_Orthopaedic prosthesis implantation instrument, 13180
  • Model / Serial
    Model: , Affected: CORAIL AMT NECK SEG 125D STD All Lots, CORAIL AMT NECK SEG 125D KLA All Lots, CORAIL AMT NECK SEG 135D STD All Lots, CORAIL AMT NECK SEG 135D KHO All Lots, CORAIL AMT NECK SEG 135D SHORT All Lots
  • Manufacturer
    DePuy France SA

Manufacturer

DePuy France SA