Device Recall ORTHO DEVELOPMENT BALANCED KNEE SYSTEM

  • Modèle / numéro de série
    Lot Number 0054891.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide -- US (states of FL and TX) and Japan.
  • Description du dispositif
    Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300, Ortho Development, Draper, Utah 84020. || The Balanced Knee System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral stability.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Ortho Development Corporation, 12187 South Business Park Dr, Draper UT 84020
  • Société-mère du fabricant (2017)
  • Source
    USFDA