Events

Alerte Ou Avis De Sécurité sur Zimmer Biomet, specific hip and trauma instruments

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Zimmer GmbH.

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
    Safety alert / Field Safety Notice
  • Date
    2018-02-15
  • Date de publication de l'événement
    2018-02-15
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/zimmer-biomet-specific-hip-and-trauma-instruments-risk-of-infection
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notes supplémentaires dans les données
  • Cause
    Manufactured by zimmer gmbh – recall due to risk of infection as affected instruments may not be adequately cleaned when using standard cleaning instructions (mda/2018/007).
  • Action
    Quarantine affected devices and obtain replacements from the manufacturer. Refer to the manufacturer’s Field Safety Notice (ref ZFA2017-332) for a full list of affected devices. Report all adverse events involving these devices to Zimmer Biomet and the MHRA or the appropriate Devolved Administration.

Device

Zimmer Biomet, specific hip and trauma instruments

Manufacturer

Zimmer GmbH
  • Adresse du fabricant
    Anne-Catherine Morancy Meister Zimmer GmbH Sulzer Allee 8 Winterthur 8404 Switzerland Tel: +41 58 854 82 37
  • 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.
  • Source
    MHRA