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 Orthopaedics.

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 064 09 18 000
  • Event Initiated Date
    2018-09-18
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13172
  • 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: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Stryker orthopaedics ("stryker") has initiated a voluntary, lot-specific recall for the knee instrument referenced above. the intent of this letter is to list known hazards potentially associated with the use of the instrument and list any risk mitigation factors. issue: stryker has discovered that the outer sterile barrier of the above-referenced instrument and lot was not fully sealed. for the above-referenced instrument observed by stryker, the inner sterile barrier seal was intact. potential hazards: technical and medical assessments are currently underway to determine any potential hazards associated with the use of the instrument. additional communication will be forwarded upon completion of the internal investigation on this issue risk mitigation: according to the instruction for use (ifu) provided within each packaged component, the end user is instructed to inspect the package and seal for damage and, if present, to discard the device. as any damage to the packaging likely will be obvious to the end user, inspection and verification prior to transferring the device to the sterile field that both the outer and inner blister is acceptable, as per the ifu, may mitigate potential risk.

Device

STERILE FLUTED HEADLESS 1/8" PIN 3.5" LONG
  • Model / Serial
    Affected Catalog Number(s): 7650-2038A Affected Lot(s): SC22130X
  • Product Description
    Non-active implantable device
  • Manufacturer
    Stryker Orthopaedics

Manufacturer

Stryker Orthopaedics
  • Manufacturer Parent Company (2017)
    Stryker
  • Manufacturers representative
    Al-Faisaliah Medical System, Riyadh (01) 2119999
  • Source
    SFDA