Device Recall ORTHO DEVELOPMENT BALANCED KNEE SYSTEM

  • Model / Serial
    Lot Number 0054891.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide -- US (states of FL and TX) and Japan.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Ortho Development Corporation, 12187 South Business Park Dr, Draper UT 84020
  • Manufacturer Parent Company (2017)
  • Source
    USFDA