Events

Alerte De Sécurité sur AnspachR Single-use Cutting Burs and Irrigation Clips

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
    2011-10-04
  • 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_20111004.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
    Field safety notice: synthes anspachr single-use cutting burs and irrigation clips medical device manufacturer, synthes, has issued a field safety notice concerning anspachr single-use cutting burs and irrigation clips used with anspachr electri and pneumatic high speed drill system. this removal is being conducted because anspachr has observed separation between the clear layers of the pouch during real time aging studies. as a result of the separation, it is possible to have a breach in the sterile barrier. this removal action is limited to product that is packaged in a tyvek pouch where the product is retained within a tube. products that are retained within a snap tray are not affected by this removal action. anspachr has not received any reports of incidents or adverse events related to this issue. according to the local supplier, affected products have been distributed in hk. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

AnspachR Single-use Cutting Burs and Irrigation Clips
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Synthes Anspach Single-use Cutting Burs and Irrigation Clips
  • Manufacturer
    Synthes

Manufacturer

Synthes