Events

Alerte De Sécurité sur Inserter for Titanium Elastic Nails

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 GmbH.

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
    2015-03-06
  • Date de publication de l'événement
    2015-03-06
  • 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_20150306b.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 gmbh inserter for titanium elastic nails medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its inserter for titanium elastic nails [part number: 359.219; lot numbers: 3163015, 8878816]. according to the manufacturer, the affected lots of the inserter for titanium elastic nails (ten) may have the potential for breakage during use. the manufacturer is not requiring an immediate return of affected product(s) as the removal of the ten inserter would prevent the performance of emergency surgery. if an inserter for ten breaks during use, there is the potential for surgical delay while an alternate trauma set is located to complete the procedure. in a worst case scenario, if the inserter for ten breaks during use, the breaking pieces may cause damage to surrounding structure and/or injury to user. the manufacturer will recall the affected products in phases. 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 06 march 2015.

Device

Inserter for Titanium Elastic Nails
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Synthes GmbH Inserter for Titanium Elastic Nails
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH