Device Recall Ovation Hip Stem, REF 2010002, Hip Stem Inserter, NonSterile, Ortho Development, Draper

  • Model / Serial
    All lots
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including AZ, CA, CO, FL, MI, NV, OR, and UT.
  • Product Description
    Ovation Hip Stem, REF 201-0002, Hip Stem Inserter, 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

Manufacturer

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