Events

Retiro De Equipo (Recall) de Device Recall Versafitcup Double Mobility Liner Inserter

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
    59043
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2709-2011
  • Fecha de inicio del evento
    2011-05-23
  • Fecha de publicación del evento
    2011-06-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100899
  • 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
    Prothesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calcium-phosphate - Product Code MEH
  • Causa
    Medacta international has recently realized that the base of the liner inserter ref 01.26.10.0018 lot 105549 of the versafitcup double mobility system could become rusty after the washing procedures. this is due to an incorrect raw material used by one of our suppliers during the production phase of this lot. for this reason, medacta international has made the decision to remove all the pieces.
  • Acción
    Medacta USA sent an "URGENT SAFETY NOTIFICATION-VERSAFITCUP DM LINER INSERTER" letter dated May 23, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory for the affected device, immediately sequester it and not use the device in surgery. The letter instructs customers to pack the affected device for shipment to Medacta USA under Return Material Authorization 1590. Customer will receive a replacement within a few days. Questions regarding this recall are directed to the Director of Regulatory and Quality at 805-437-7085 ext. 26.

Device

Device Recall Versafitcup Double Mobility Liner Inserter
  • Modelo / Serial
    Lot code: 105549
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution--USA (nationwide) including the states of CA, ID, IL, and OH, and 9 products to foreign countries.
  • Descripción del producto
    Product Brand Name: Versafitcup Double Mobility Liner Inserter || Product Generic Name: Versafitcup Double Mobility Liner Inserter || Model Number: 01.26.10.0018 || The hip prosthesis is designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patients condition should be due to one or more of: " Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriactic arthritis, Congenital hip dysplasia, Ankylosing spondylitis. " Avascular necrosis of the femoral head. " Acute traumatic fracture of the femoral head or neck. " Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present. " Dislocation risks.
  • 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