Events

Alerta De Seguridad para Knee Arthroplasty System / Knee Prosthesis; models: 6307-00-006 / 6307-00-008 / 6307-00-009; registration 80199020013; risk class III; lots: 61988031; 62054615; 62041152; 6,180,029; 61806575; 62005748; 61815746; 62041157; 61822616; 62005756; 62054626; 62068198; 62128274; 61831823; 61831831; 61850057; 61824682.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDSINTESE Importação, exportação e comércio Eireli.; Zimmer Inc..

¿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
    1812
  • Fecha
    2016-02-01
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    The company made a potential risk assessment and concluded that packaging adhesion is unlikely to cause an adverse effect on the patient or even the implant. As reported by the company, if wear particles generated from the film / adhesion residue of LDPE packaging were expected to elicit similar biological reactions from those of ultra high molecular weight polyethylene and are unlikely to increase the possibility of peri-prosthetic osteolysis .
  • Causa
    Some components of highly polished implants were packed in a low density polyethylene (ldpe) casing with the potential to adhere to the implants.
  • Acción
    Pick up and return to the manufacturer. Action code FAM-03. The distributors must carry out the traceability of the products in their inventory. When you find products related to lots of this field action, it segregates them. The company will collect the affected units.

Device

Knee Arthroplasty System / Knee Prosthesis; models: 6307-00-006 / 6307-00-008 / 6307-00-009; regi...

Manufacturer

MEDSINTESE Importação, exportação e comércio Eireli.; Zimmer Inc.
  • Source
    ANVSANVISA