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 Zimmer 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 086 06 11 000
  • Event Initiated Date
    2011-06-25
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=561
  • 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 packages contained the wrong patient label. where the wrong patient label is being used for documentation of the implanted device, the wrong lot and size will be recorded in the patient record. with later inquiries, this could potentially lead to an incorrectly prepared revision surgery (wrong size insert selected).

Device

Prosthesis, Acetabulum prosthesis
  • Model / Serial
    PE Alpha Hooded Insert HH/28; Model 01.00010.308; Lot 2463499 PE Alpha Hooded Insert LL/28; Model 01.00010.312; Lot 2462484 Durasul alpha Insert Neutral KK/36; Model 01.00013.711; Lot 2541553 Durasul Alpha Insert With Rim II/28; Model 01.00013.309; Lot 2541785 Durasul Alpha Insert Neutral GG/28; Model 01.00013.207; Lot 2541769 Durasul Alpha Insert With Rim MM/28; Model 01.00013.313; Lot 2541789
  • Product Description
    Prosthesis, Acetabulum prosthesis
  • Manufacturer
    Zimmer inc

Manufacturer

Zimmer 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
    Ebrahim M. Al-Mana & Bros. Co. Ltd.
  • Source
    SFDA