Events

Retiro De Equipo (Recall) de Device Recall Versafitcup Total Hip SystemImpacting Ring

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medacta Usa Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    64294
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0878-2013
  • Fecha de inicio del evento
    2010-01-15
  • Fecha de publicación del evento
    2013-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115770
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
  • Causa
    Medacta usa is recalling versafitcup impacting ring because the impaction ring may not fit properly in the implant shell in all cases. this could result in surgical delay potentially increasing possible complications under anesthesia, having to ream up to a larger shell size leaving less bone than planned and repositiong/removal of the shell after initial impaction.
  • Acción
    Medacta USA sent notification letters dated 1/15/10 to Sales Representatives for customers that purchased the Versafitcup Impacting Ring. The letter informed the customers of the problem identified and the actions to be taken. Customers are informed that Medacta USA personnel will contact them by telephone to provide them with a RMA number. Customers are informed that they will receive a new set of redesigned/reworked impacting rings and a second near the end of the January 2010. Customers with questions are instructed to contact the firm at (805) 437-7085.

Device

Device Recall Versafitcup Total Hip SystemImpacting Ring
  • Modelo / Serial
    Reference Number Lot Number Reference Number Lot Number 01.26.10.0133: 095920, 096050, 096050A; 01.26.10.0138: 095925, 096055, 096055A; 01.26.10.0134: 095921, 096051, 096051A; 01.26.10.0139: 095926, 096056, 096056A; 01.26.10.0135: 095922, 096052, 096052A; 01.26.10.0140: 095927, 096057, 096057A; 01.26.10.0136: 095923, 096053, 096053A; 01.26.10.0141: 095928, 096058, 096058A; 01.26.10.0137: 095924, 096054, 096054A; 01.26.10.0142: 095929, 096059, 096059A.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including the states of ID, CO, TX, WI, NY, CT, WA, CA, UT, and AZ.
  • Descripción del producto
    Versafitcup Impacting Ring || Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.10.0139 (58mm), 01.26.10.0140 (60mm), 01.26.10.0141 (62mm), 01.26.10.0142 (64mm). || Designed for cementless use in total hip arthroplasty.
  • Manufacturer
    Medacta Usa Inc

Manufacturer

Medacta Usa Inc
  • Dirección del fabricante
    Medacta Usa Inc, 4725 Calle Quetzal Ste B, Camarillo CA 93012-8429
  • Empresa matriz del fabricante (2017)
    Medacta Holding Sa
  • Source
    USFDA