Events

Retiro De Equipo (Recall) de Smith & Nephew

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 Smith & Nephew, Inc., Endoscopy Div..

¿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
    72205
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0157-2016
  • Fecha de inicio del evento
    2015-09-10
  • Fecha de publicación del evento
    2015-10-22
  • 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=140174
  • 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
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • Causa
    Sterility of device is compromised due to breach in the packaging.
  • Acción
    Smith & Nephew issued Recall Notification Letter dated September 10, 2015 via overnight Federal Express. Customers were requested to inspect inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. Complete the Inventory Return Certification Form on the following page, indicating the lot numbers and quantities that need to be returned and include your phone and fax number in the spaces provided. If you do not have product to return, please place an x in the column No product to return. Send the completed form to the Smith & Nephew's Field Action Department via email at FieldActions@smithnephew. com or fax +1-901-566-7975 to obtain a return authorization (RA) number. Return any affected product to the address listed on the Inventory Return Certification Form. Please indicate the RA number on your return shipment.

Device

Smith & Nephew
  • Modelo / Serial
    567531 50182767 50242031 50311086 50354626 50396028 50419909 50451050 50481583 586717 50193108 50251239 50311900 50361147 50400191 50423797 50451742 L50195027 50023445 50195027 50254749 50322127 50372399 50402518 50427083 50452777 50031093 50200477 50257710 50326789 50375128 50404802 50431408 50455222 50089906 50207485 50260093 50331945 50376693 50405482 50432856 50456255 50112893 50214248 50266143 50337081 50379780 50408076 50433676 50460255 50129647 50218992 50279513 50337265 50381258 50408437 50442599 50469461 50160551 50221872 50285674 50337464 50389830 50411651 50443725 50476967 50175558 50230673 50297948 50344790 50389832 50414388 50447281 50477073 50179006 50236269 50302624 50348085 50395177 50414909 50448747 50480681
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide, Canada, Austria, Australia, Belgium, China, Spain, Finland, France, Great Britain, Greece, Germany, Hungary, India, Italy, Japan, Korea, Lithuania, Latvia, Netherlands, Poland, Portugal, Sweden, Thailand, Turkey, Ukraine and Venezuela
  • Descripción del producto
    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile || Part Number: 7209236 || Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
  • Manufacturer
    Smith & Nephew, Inc., Endoscopy Div.

Manufacturer

Smith & Nephew, Inc., Endoscopy Div.
  • Dirección del fabricante
    Smith & Nephew, Inc., Endoscopy Div., 130 Forbes Blvd, Mansfield MA 02048
  • Empresa matriz del fabricante (2017)
    Smith & Nephew plc
  • Source
    USFDA