Events

Alerta De Seguridad para Inserter for Titanium Elastic Nails

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Synthes GmbH.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2015-03-06
  • Fecha de publicación del evento
    2015-03-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150306b.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Synthes GmbH Inserter for Titanium Elastic Nails
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH