Device Recall Omnifit FC Cemented Stem

  • Modèle / numéro de série
    6093-1035 OMNIFIT-FC CEMENTED STEM 28RMLE and 6093-1035 ONMIFIT FC CEMENTED STEM 3DHME
  • 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
    Omnifit FC Cemented Stem || These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip 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