Events

Alerte De Sécurité sur Guide Wire Ø 2.5 mm, with drill tip, length 300 mm, Cobalt-Chrome Alloy

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par 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
    2013-05-08
  • Date de publication de l'événement
    2013-05-08
  • 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_20130508e.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 guide wire ø 2.5 mm, with drill tip, length 300 mm, cobalt-chrome alloy medical device manufacturer, synthes, has issued a field safety notice concerning guide wire ø 2.5 mm, with drill tip, length 300 mm, cobalt-chrome alloy with part number 338.002. according to synthes, wrong material (stainless steel) is indicated on the product label. the product is made of cobalt chrome (l605). the mislabelled product, if detected, may result in user dissatisfaction and use of an alternative product with no harm anticipated. there is an unlikely potential that a user may desire to use a stainless steel guide wire because the patient has a known sensitivity to cobalt chrome-alloy. although highly unlikely, if this situation were to occur the patient could experience an adverse tissue reaction. according to the local supplier, the affected devices were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 08 may 2013.

Device

Guide Wire Ø 2.5 mm, with drill tip, length 300 mm, Cobalt-Chrome Alloy
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Synthes Guide Wire Ø 2.5 mm, with drill tip, length 300 mm, Cobalt-Chrome Alloy
  • Manufacturer
    Synthes

Manufacturer

Synthes