Alerta De Seguridad para Anchoring Sutures and Needles System JUGGERKNOT

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Biomet Sport Medicine || Zhejiang Biomet Medical Products Co. Ltd. || Changzhou Biomet Medical Devices Co. Ltd.

¿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
  • ID del evento
  • Número del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that the tyvek seal could be weak, compromising the sterile barrier, leading to adverse events on patients.


  • Modelo / Serial
    110005306, 110005307, 14-405040, 281001100, 805065080, 900360, 900364, 904723, 904755, 904756, 904834, 912029, || 912030, 912031, 912057, 912068, 912071 and 912076, lots || specific.
  • Descripción del producto
    The soft anchors JUGGERKNOTTSON an implant completely based on suture that binds to fixation, detejido soft - bone. The JUGGERKNOT soft anchors consist of a manual assembly used to deploy a pre-loaded implant, the JUGGERKNOT soft anchor implant is a two-piece anchor design and the second one is a two suture strips, when the strip is braided the anchor part secures the bone, setting The soft tissue represents the next generation in anchoring suture technology. The 1.4mm anchor deployment design is a system entirely based on suture and is the first of its kind.
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source