Events

Recall of Coated Implant_Delta Extend

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
    22011
  • Event Initiated Date
    2017-09-21
  • 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 determined that lots produced in a specific machine were manufactured in a manner in which the post's diameter is out-of-specification. further investigation determined that the issue is related to the circularity of the cylinder. the circularity issue may cause the epiphysis to interfere with the stem and the two implants (epiphysis and stem) cannot be assembled.
  • Action
    Product to be returned to supplier

Device

Coated Implant_Delta Extend
  • Model / Serial
    Model: , Affected: Modular Centered Epiphysis Size 1 HA, Modular Eccentric Epiphysis Size 1 Left HA, Modular Eccentric Epiphysis Size 1 Right HA, Modular Centered Epiphysis Size 2 HA, Modular Eccentric Epiphysis Size 2 Left HA, Modular Eccentric Epiphysis Size 2 Right HA
  • Manufacturer
    DePuy France SA

Manufacturer

DePuy France SA