Events

Retiro De Equipo (Recall) de Radiesse Injectable Implant

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 Merz Aesthetics, 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
    58614
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2221-2011
  • Fecha de inicio del evento
    2011-04-06
  • Fecha de publicación del evento
    2011-05-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99710
  • 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
    Implant, dermal, for aesthetic use - Product Code LMH
  • Causa
    Merz aesthetics, inc. is recalling 1 lot (1034417) of radiesse 1.3 cc implant. the lot was supposed to be scrapped because it had failed to meet its loss on drying (lod) specification. unfortunately it had been marked as approved, released and shipped.
  • Acción
    The firm, Merz Aesthetics, Inc., contacted its consignee/customer via e-mail on April 6, 2011. The e-mail states the product, problem and action to be taken. The customer was instructed to follow up with the concerned and inform the status time to time to the Recall Coordinator. The product was confirmed to be quarantined and has been requested to be sent back. If you need any additional information regarding this issue or if you have any questions, contact the International Regulatory Affairs Specialist at 262-835-3300 ext. 3081.

Device

Radiesse Injectable Implant
  • Modelo / Serial
    Lot 1024417
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    International only: Taiwan.
  • Descripción del producto
    Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before 2013-01, Ref 8046M7, Lot 1024417, Manufactured by: BioForm Medical Inc, 4133 Courtney Rd #10 Franksville, WI 53126. || Subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as masolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.
  • Manufacturer
    Merz Aesthetics, Inc.

Manufacturer

Merz Aesthetics, Inc.
  • Dirección del fabricante
    Merz Aesthetics, Inc., 4133 Courtney Rd, Suite 10, Franksville WI 53126-9127
  • Empresa matriz del fabricante (2017)
    Merz Holding Gmbh & Co. Kg
  • Source
    USFDA