Device Recall POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar)

  • Modèle / numéro de série
    Lot Numbers: A57835, A57837, A58509, A59084, A59446, A59547, A60948
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.
  • Description du dispositif
    smith&nephew; POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only || The subject cardan is used in conjunction with a curved stem impactor used to implant the POLARSTEM hip stem. The hip stem is mounted on the screw at the tip of the instrument, and the stem is then impacted into the femur. After impaction, the surgeon uses a knob at the end of the cardan to unscrew the implanted stem from the instrument
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • Société-mère du fabricant (2017)
  • Source
    USFDA