Device Recall Stryker Orthopedics

  • Modèle / numéro de série
    510K 983382  Lot code 49073501
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including NY, OH, PA, and TX.
  • Description du dispositif
    Trident PSL HA Solid Back 50 mm || Includes Dome Hole Plug || Ref 540-11-50E || Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patients prepared acetabulum and a linger (polyethylene or alumina ceramic) is then locked into the shell. The femoral head component of the total hip system articulates with the acetabular liner.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Société-mère du fabricant (2017)
  • Source
    USFDA