Events

Alerte De Sécurité sur Handle, flexible

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

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
    2013-04-16
  • Date de publication de l'événement
    2013-04-16
  • 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_20130416.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: synthes handle, flexible medical device manufacturer, depuy synthes, has issued a field safety notice concerning the “handle, flexible [no.: 355.220]”. all lot numbers of the old handle (355.280) are affected. the manufacturer is initiating a voluntary recall of all lots of the "handle, flexible, for no. 355.220" (355.280) which is part of the simplified universal nail system (sun) and the universal nail system (uni), due to the potential lack of the ability to thoroughly clean the instrument. it was reported by the evaluation department in monument/usa that while checking the instrument set a discharge from the handle, flexible was noted. additionally, an investigation was unable to validate the ability to adequately clean the instrument. there have been no complaints or adverse events with regards to the issue. the manufacturer advises users to remove the affected product from use and return them to synthes. the handles in the field will be replaced with a newly design handle. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 april 2013.

Device

Handle, flexible
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Synthes Handle, flexible
  • Manufacturer
    DePuy Synthes

Manufacturer

DePuy Synthes