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 157 06 15 000
  • Event Initiated Date
    2015-06-29
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=7876
  • 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 affected parts and lots of the pull reduction devices may have been manufactured to an incorrect hardness specification which could result in intraoperative breakage. in the event of an intraoperative breakage a surgical delay would most likely occur. breakage of the instrument into fragments during active use could lead to a significant prolongation of surgery time as the surgeon attempts to retrieve the pieces including use of radiographic imaging to determine location and size of fragment. efforts at retrieving fragments may also require additional intraoperative maneuvers e.G. supplementary incisions that were not previously intended, leading to soft tissue damage.

Device

Pull Reduction Device
  • Model / Serial
    Manufactured prior to May 15, 2013 ( specific lot numbers are included in the Field Safety Notice )
  • Product Description
    Temporal bone holder
  • Manufacturer
    Synthes Inc

Manufacturer

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