Events

Alerta De Seguridad para CORTICAL BOLT SCREW 4.5MM MDN, model 2253-XX-45. Registration 80245480011

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por WM WORLD MEDICAL IMP EXP LTDA; 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
    1590
  • Fecha
    2015-05-26
  • 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 informs that Zimmer received a single claim in the world that could possibly be attributed to this dimensional incompatibility of the 4.5mm M / DN bolt. No injury injury or injury to the patient as a result of the incident was reported. The occurrence estimate is 0.00033%. In Brazil, among the 122 units implanted there was no adverse event reported. The company directs health services to report any adverse events.
  • Causa
    Zimmer is starting a recall of the 4.5mm cortical bolts of the m / dn system because it was found during the revision of the historical project files that the entire scope of 4.5mm m / dn cortical bolts could present dimensional incompatibility with the m system / dn. dimensional incompatibility can occur only in the worst case of plant specifications, where multiple dimensional parameters are within the maximum material limits (it means that the stem bore is smaller than possible and the outer diameter of the bolt is as wide as possible). the affected items were distributed from january 2006 to february 2015.
  • Acción
    1. Ensure that affected personnel are aware of the information; 2. Locate all affected products in Annex 1 and remove them from use immediately (segregation / quarantine); 3. The local sales representative Zimmer will make the recall the affected products; 4. Complete the "Acknowledgment of Responsibility Form" and send to - corporatequality.postmarket@zimmer.com and / or sac@wmie.com.br; 5. If after reviewing this notice you have additional doubts please contact your local Zimmer dealer. Adverse effects related to these products in Brazil should be reported directly to the local sales representative, or www.wmie.com.br and through NOTIVISA.

Device

CORTICAL BOLT SCREW 4.5MM MDN, model 2253-XX-45. Registration 80245480011

Manufacturer

WM WORLD MEDICAL IMP EXP LTDA; ZIMMER INC
  • Source
    ANVSANVISA