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 Medacta International SA.

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 133 04 15 000
  • Event Initiated Date
    2015-04-28
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=7551
  • 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
    Medacta received a complaint from the field in which it was reported that in two different packages of the gmk hinge tibial augmentation size 4 - 10 mm of the same lot 145129 there were screws of 5 mm length instead of 10 mm.

Device

GMK Hinge Tibial Augmentation
  • Model / Serial
    - GMK Hinge Tibial Augmentation # 4/10 mm - Reference code : 02.09.TA410 - Lot number : 145129
  • Product Description
    Knee arthroplasty wedge
  • Manufacturer
    Medacta International SA

Manufacturer

Medacta International SA