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 Newdeal SAS.

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 091 10 11 000
  • Event Initiated Date
    2011-10-30
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=970
  • 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
    Newdeal sas has recently become aware that one batch of snap-off® screw dia. 2.7mm- length 20mm non sterile (catalog number 117 020 – batch ek79) has been etched and labeled with specifications of the snap-off® screw dia. 3.0mm length 20mm sterile (catalog number 117 120s – batch en5j). although we have not received any information showing that the use of such affected devices had significant consequence on patients, as a preventive measure, newdeal sas has made a decision to conduct a recall.

Device

SNAP-OFF SCREW
  • Model / Serial
    Diameter:2.7 mm*length 20 mm (non sterile) Diameter:3.0 mm*length 20 mm (sterile) Model: 117 020 (non sterile) and 117 120S (sterile) Lot/batch no: EK79 (117 020) EN5J (117 020S)
  • Product Description
    SCREW, sterile, non sterile
  • Manufacturer
    Newdeal SAS

Manufacturer

Newdeal SAS