Events

Retiro De Equipo (Recall) de Positioner/Aligner

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 Limacorporate S.p.A.

¿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
    78109
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0068-2018
  • Fecha de inicio del evento
    2017-09-08
  • Estado del evento
    Completed
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158680
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical strength of the device and possible breakage during impaction when the instrument is subjected to repeated multi-axial stresses.
  • Acción
    The Firm, Lima Corporate has notified the US agents of the recall and asked to check each single set with the affected product codes, identify the items and remove them from the inventory. The US distributors have also been instructed to fill out and sign a response document specifying the quantities returned. For further questions, please call (800) 962-2578.

Device

Positioner/Aligner
  • Modelo / Serial
    Lot # 15AG0HJ, 15AG0HQ, 15AG0UY, 15AG00P, 15AG040, 15AG08Y, 14AG243, 15AG00Q, 15AG0UZ, 15AG0V0, 15AG0HN, 16AG02J
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution and to the countries of : Australia, Austria, Belgium, Brazil, Czech Republic, Germany, Italy, New Zealand, Poland, Russia, Slovakia, Slovenia, Spain, South Africa, Switzerland, Turkey, UK and Germany
  • Descripción del producto
    Delta Cup Beater  Positioner - Aligner, model # 9057.20.555 || Used during implantation of the Delta Acetabular System
  • Manufacturer
    Limacorporate S.p.A

Manufacturer

Limacorporate S.p.A
  • Dirección del fabricante
    Limacorporate S.p.A, Via Nazionale 52, Frazione Villanova, San Daniele del Friuli Italy
  • Empresa matriz del fabricante (2017)
    Emil Holding Ii Sarl
  • Source
    USFDA