Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by DePuy International Limited.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 140 05 18 000
  • Event Initiated Date
    2018-05-30
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12696
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    A series of complaints have been received regarding debris/material being found behind the o-rings for the corail neck trials. this was evaluated through product impact assessment (pia 1125328) which concluded that this issue does not present any additional risk to the patient. however, as the ongoing investigation requires the completion of a cleaning verification study, it was considered necessary to implement interim corrective actions. the need for this has been re-iterated through discussions with the irish health authority (hpra).

Device

CORAIL AMT Neck Trials Surgical Instruments
  • Model / Serial
    L94003 - L94004 - L94005 - L94006 - L94007
  • Product Description
    Non-active implantable devices
  • Manufacturer
    DePuy International Limited

Manufacturer

DePuy International Limited
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Manufacturers representative
    Johnson & Johnson Medical Meddile East, Riyadh, (01) 4603292
  • Source
    SFDA