Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par Zimmer inc.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 086 06 11 000
  • Date de mise en oeuvre de l'événement
    2011-06-25
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=561
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    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
  • Modèle / numéro de série
    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
  • Description du dispositif
    Prosthesis, Acetabulum prosthesis
  • Manufacturer
    Zimmer inc

Manufacturer

Zimmer inc
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “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.
  • Représentant du fabricant
    Ebrahim M. Al-Mana & Bros. Co. Ltd.
  • Source
    SFDA