Device Recall Alumina Ceramic Femoral Head

  • Model / Serial
    All lots.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution --- including USA and countries of Austria, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Dubai, England, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Korea, Lebanon, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Slovakia, Spain, Switzerland and Ukraine.
  • Product Description
    Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter, neck length -3.5 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-028-01 and 00-6428-028-01. || The Alumina Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA