Events

Alerte De Sécurité sur Standard Offset Cup Impactor

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Greatbatch Medical.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2014-03-13
  • Date de publication de l'événement
    2014-03-13
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140313a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: greatbatch medical standard offset cup impactor the united states food and drug administration (fda) has issued a medical device safety alert concerning standard offset cup impactor manufactured by greatbatch medical. the affected device was manufactured from january 2004 through january 2013 and distributed from january 2004 through december 2013. the manufacturer has identified through internal sterility assurance level validation testing that a sterility assurance level of 10-6 is not achieved on the standard offset cup impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current instructions for use provided with the device. the manufacturer has not received any reports of deaths, illnesses, injuries, or other adverse effects associated with this issue. greatbatch has developed new sterilization recommendations that meet acceptable sterility assurance levels (aami st79 standard). customers who have the affected product should immediately begin utilizing the new sterilization instructions. for details, please refer to the following fda websites: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1119-2014&w=03122014&lang=eng http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm388928.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm389005.Htm http://www.Fda.Gov/safety/recalls/ucm388883.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 march 2014.

Device

Standard Offset Cup Impactor
  • Modèle / numéro de série
  • Classification du dispositif
    Orthopedic Devices
  • Description du dispositif
    Medical Device Safety Alert: Greatbatch Medical Standard Offset Cup Impactor
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical