Events

Retiro De Equipo (Recall) de Device Recall ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES

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 MicroPort Orthopedics 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
    74785
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2698-2016
  • Fecha de inicio del evento
    2016-06-21
  • Fecha de publicación del evento
    2016-09-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148453
  • 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, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
  • Causa
    Advance(r) ha coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
  • Acción
    MicroPort sent an Urgent Field Safety Notice dated June 22, 2016, to all affected customers. The firm requested customers complete the enclosed form and return by fax 1-901-451-6032 or by email to Postmarket@ortho.microport.com. Customers were also requested to return the affected product. Non-responding consignees will be notified after 30 days. For questions regarding this recall call 901-867-4771.

Device

Device Recall ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES
  • Modelo / Serial
    all codes
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
  • Descripción del producto
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 6 FEMUR & SIZE 6 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
  • Manufacturer
    MicroPort Orthopedics Inc.

Manufacturer

MicroPort Orthopedics Inc.