Events

Alerta De Seguridad para radial head prosthesis – MoPyC – Head

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

¿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
    2014-01-22
  • Fecha de publicación del evento
    2014-01-22
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140122c.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: tornier radial head prosthesis – mopyc – head medical device manufacturer, tornier, has issued a field safety notice concerning radial head prosthesis – mopyc – head with the following details: model: small catalogue number: ptr-h18 serial numbers.: 0743amxxx - 5886amxxx - cb2-425/xx - cb2-243/xx - cb2-244/xx - cb2-245/xx - cb2-146/xx according to the manufacturer, complaints were recorded concerning some cases of broken mopyc heads. the manufacturer has identified that some lots, manufactured in limit of tolerances, had a slightly more frequent risk of rupture. the manufacturer advises users to quarantine and return the affected products. if you are in possession of the products, please contact your supplier for necessary actions. posted on 22 jan 2014.

Device

radial head prosthesis – MoPyC – Head
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Tornier radial head prosthesis – MoPyC – Head
  • Manufacturer
    Tornier

Manufacturer

Tornier