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 Stryker.

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 001 07 17 000
  • Event Initiated Date
    2017-07-03
  • Event Country
  • Event Source
    SFDA
  • Event Source URL
  • 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
    In conjunction with an industry-wide labeling update initiated by the fda, additional information is being added to the instructions for use (ifu) for bone cement products. cement leakage into the venous system during vertebroplasty or kyphoplasty procedures is recognized as a possible complication and warnings regarding pulmonary embolism are addressed in the current ifu. intracardiac bone cement embolism will also be referenced in the updated version of the ifu.

Device

  • Model / Serial
    Multiple Part numbers of the affected device are provided in the attached FSN
  • Product Description
    Bone Cement
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturers representative
    Al-Faisaliah Medical System
  • Source
    SFDA