Device Recall TRI PRESSFIT STEM

  • Modèle / numéro de série
    5565-S-015 TRI PRESS-FIT STEM 15MM X 100MM M3M07B, 5565-S-016 TRI PRESS-FIT STEM 16MM X 100MM M3M01B, 5565-S-016 TRI PRESS-FIT STEM 16MM X 100MM M3M01E, 5565-S-017 TRI PRESS-FIT STEM 17MM X 100MM M3M03A, 5566-S-012 TRI PRESS-FIT STEM 12X150MM M3L11F, 5566-S-013 TRI PRESS-FIT STEM 13X150MM M3L12B, and  5566-S-018 TRI PRESS-FIT STEM 18X150MM M3L17D
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
  • Description du dispositif
    Triathlon-Press-Fit Stem || These devices are modular components of a total knee system. These modular stems are intended for use with femoral and tibial components in primary or revision total knee arthroplasty.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430
  • Société-mère du fabricant (2017)
  • Source
    USFDA