Events

Retiro De Equipo (Recall) de Device Recall Restoris Multicompartmental Knee (MCK) System

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 Mako Surgical Corporation.

¿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
    67444
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1132-2014
  • Fecha de inicio del evento
    2014-01-09
  • Fecha de publicación del evento
    2014-03-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125464
  • 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
    Nationwide distribution including AZ, FL, HI, OH, MI, NC NH, WA, TX, WI, OK, CA, RI, LA, ID, IL, IN, - Product Code NPJ
  • Causa
    The product may be mislabeled and could result in the incorrect implant being used.
  • Acción
    MAKO Surgical Corporation sent an Important Medical Device Recall Notice letter dated January 9, 2014 to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. The letter informed the customers that their MAKOplasty Sales Specialist will coordinate with them the return of the product that will be replaced at no charge. Customers were asked to sign and return the Acknowledgement form to MAKO Surgical using one of the following methods: Email, Fax or Mail. For questions, customers were instructed to call (954) 628-1721. For questions regarding this recall call 954-628-0607.

Device

Device Recall Restoris Multicompartmental Knee (MCK) System
  • Modelo / Serial
    Part Number #180704-1, Lot #12151013-1.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide distribution including AZ, FL, HI, OH, MI, NC NH, WA, TX, WI, OK, CA, RI, LA, ID, IL, IN, and TN.
  • Descripción del producto
    Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. || Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.
  • Manufacturer
    Mako Surgical Corporation

Manufacturer

Mako Surgical Corporation
  • Dirección del fabricante
    Mako Surgical Corporation, 2555 Davie Rd Ste 110, Plantation FL 33317-7424
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA