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 Synthes Inc.

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 087 03 11 000
  • Event Initiated Date
    2011-03-22
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=254
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    The labels on pliviopore implants do not reflect the actual shelf life as foreseen.

Device

PlivioPore
  • Model / Serial
    ( Lot numbers are attached) PlivioPore, size 7 mm, sterile 495.037S PlivioPore, size 9 mm, sterile 495.039S PlivioPore, size 10 mm, sterile 495.040S PlivioPore, size 11 mm, sterile 495.041S PlivioPore, size 12 mm, sterile 495.042S PlivioPore, size 13 mm, sterile 495.043S PlivioPore, size 15 mm, sterile 495.045S
  • Product Description
    PlivioPore is an implant system for posterior lumbar intercorporeal fusion.
  • Manufacturer
    Synthes Inc

Manufacturer

Synthes Inc
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Manufacturers representative
    Isam Economic Co., Riyadh, (01) 4600846
  • Source
    SFDA