Device Recall REFlex VSP Prosthetic foot

  • Modelo / Serial
    Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007. Inner tube serial numbers beginning with 1472 through 1677 are suspect. This number is not traceable to the customer. The recall will be based on shipments made during the period that these numbers were in use. (sold between 25th of August and October 2006)
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide in US plus Worldwide distribution in Canada, Austria, Switzerland, Czech Republic, Germany, Spain, France, United Kingdom, Greece, Israel, Italy, Netherlands and Norway.
  • Descripción del producto
    Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber, Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Ossur, Grjothals 5, Reykjavik Ireland
  • Source
    USFDA