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 Biomet 3i 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 042 01 11 000
  • Event Initiated Date
    2011-01-18
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=57
  • 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: http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    (january 17 , 2011 )the implant(s) may contain a manufacturing defect. this condition may be present in a small percentage of the lot 910695 and it relates to a shallow depth of the internal hex. the condition, if present, may prevent the driver; cover screw or abutment from fully engaging the implant. a complaint was received from a customer and the investigation showed that an incorrect machine tool was used during the manufacturing of the product and that related inspection protocols weren’t adequately followed.

Device

OsseoTite®Certain®Implant
  • Model / Serial
    OsseoTite Certain Implant 5X 11.5 mm Model IOSS511 , Lot/batch no. 910695
  • Product Description
    Dental implant endosseous
  • Manufacturer
    Biomet 3i Inc

Manufacturer

Biomet 3i Inc
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Manufacturers representative
    Asnan Medical Services , Riyadh , (01) 4621613
  • Source
    SFDA