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 080 11 14 000
  • Event Initiated Date
    2014-11-18
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=6753
  • 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
    A product of the above mentioned lot of 2.0 mm drill bits with 14mm stop/zero-p had been manufactured with a tip that was 16mm. this 16mm component was then incorrectly packaged, labeled, and distributed as a 14mm drill bit.

Device

Drill Bit 2.0mm drilling depth 14mm, 3-f1ute, for Quick Coupling
  • Model / Serial
    Part Number: 03.617.914 Lot Number: 6496070
  • Product Description
    Drill Bit 0 2.0mm drilling
  • Manufacturer
    Synthes Inc

Manufacturer

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