Events

Alerta De Seguridad para metal and PEEK suture anchors

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

¿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
    2012-08-08
  • Fecha de publicación del evento
    2012-08-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120808a.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: smith and nephew metal and peek suture anchors medical device manufacturer, smith and nephew, has issued a field safety notice concerning metal and peek suture anchors. many of the affected products are from the bioraptor™, footprint, healicoil™ and twinfix™ product lines. according to the manufacturer, there was a class ii recall for certain metal and peek suture anchors due to a packaging issue. specifically, the manufacturer has identified pin holes in a small number of pouches, which constitutes a breach of the sterile barrier. according to the local supplier, smith and nephew, the affected devices were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 8 august 2012.

Device

metal and PEEK suture anchors
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Smith and Nephew metal and PEEK suture anchors
  • Manufacturer
    Smith and Nephew

Manufacturer

Smith and Nephew