Events

Alerte De Sécurité sur ULTRA FAST-FIX Knot Pusher/Suture Cutter, Straight

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

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
    2015-05-05
  • Date de publication de l'événement
    2015-05-05
  • 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_20150505a.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: smith & nephew ultra fast-fix knot pusher/suture cutter, straight medical device manufacturer, smith & nephew, inc., has issued a medical device safety alert concerning ultra fast-fix knot pusher/suture cutter, straight. [product number: 72201537; batch number: all batches manufactured from april 2010 to april 2014 which have corresponding expiration dates of april 2015 to april 2019]. the manufacturer’s internal investigation has found that the packaging material and design to be insufficient to prevent the ultra fast-fix knot pusher suture cutter’s sharp edges from potentially puncturing the pouch and rendering the device unsterile. an unsterile device used during an arthroscopic repair could potentially lead to a post-operative infection. product recall is ongoing. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 may 2015.

Device

ULTRA FAST-FIX Knot Pusher/Suture Cutter, Straight
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Smith & Nephew ULTRA FAST-FIX Knot Pusher/Suture Cutter, Straight
  • Manufacturer
    Smith & Nephew

Manufacturer

Smith & Nephew