Device Recall Ovation Hip Stem, REF 2010103, Offset Stem Inserter LT, NonSterile, Ortho Development, Draper

  • Modelo / Serial
    All lots
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including AZ, CA, CO, FL, MI, NV, OR, and UT.
  • Descripción del producto
    Ovation Hip Stem, REF 201-0103, Offset Stem Inserter LT, Non-Sterile, Ortho Development, Draper, Utah 84020. || The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter is an instrument used to seat the hip stem in the femur. There is a notch in the top of the hip stem, and the hip stem inserter has a corresponding tip at the end of the instrument. The tip of the inserter is designed to fit into the notch of the hip stem, as a guide. Once this is inserted, the surgeon will tap on the opposite end of the inserter with a hammer to seat the press-fitted stem assembly.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Ortho Development Corporation, 12187 South Business Park Dr, Draper UT 84020
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA