Events

Alerte Ou Avis De Sécurité sur Standard Offset Cup Impactor

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 Greatbatch Medical.

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
  • ID de l'événement
    MDA/2014/031
  • Numéro de l'événement
    CON437749
  • Date
    2014-07-24
  • Date de publication de l'événement
    2014-07-24
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON437749?tabName=allTabs
  • 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
    Potential for infection from inadequately sterilized devices. the manufacturer has validated new sterilization parameters for these devices to address this issue. these parameters are provided in the manufacturer’s field safety notice (fsn) issued in march 2014. greatbatch originally sent a notification in january 2014, with one acceptable sterilization parameter, (validated to a sterility assurance level (sal) of at least 10-6). greatbatch has now validated an additional sterilization parameter for use with their device. both acceptable parameters are provided in the updated fsn dated march 2014. the mhra is issuing this medical device alert to ensure that all users are aware of the manufacturer’s updated fsn.
  • Action
    Identify affected devices. Follow the updated sterilization instructions described in the FSN. All staff involved in sterilization of these devices. All orthopaedic staff that use these devices.

Device

Standard Offset Cup Impactor
  • Modèle / numéro de série
  • Description du dispositif
    Greatbatch Medical: Standard Offset Cup Impactor
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical