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 Stryker Trauma AG.

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 021 04 12 000
  • Event Initiated Date
    2012-04-10
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=1652
  • 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
    Stryker osteosynthesis has become aware of the fact that the cutting performance of the combo reamer drill might be not as expected which could increase the time for drilling during the surgery or even make it necessary to exchange the instrument or to change to another op technique.

Device

Medullary canal orthopaedic reamer, rigid, Combo Reamer Drill, Combo Reamer Assembly
  • Model / Serial
    Serial no.: 704005, 704005‐10, 704006 Lot/batch no.: see attached list
  • Product Description
    Medullary canal orthopaedic reamer, rigid
  • Manufacturer
    Stryker Trauma AG

Manufacturer

Stryker Trauma AG
  • Manufacturer Parent Company (2017)
    Stryker
  • Manufacturers representative
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA