Device Recall Versafitcup Double Mobility Liner Inserter

  • 모델명 / 제조번호(시리얼번호)
    Lot code: 105549
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution--USA (nationwide) including the states of CA, ID, IL, and OH, and 9 products to foreign countries.
  • 제품 설명
    Product Brand Name: Versafitcup Double Mobility Liner Inserter || Product Generic Name: Versafitcup Double Mobility Liner Inserter || Model Number: 01.26.10.0018 || The hip prosthesis is designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patients condition should be due to one or more of: " Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriactic arthritis, Congenital hip dysplasia, Ankylosing spondylitis. " Avascular necrosis of the femoral head. " Acute traumatic fracture of the femoral head or neck. " Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present. " Dislocation risks.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Medacta Usa Inc, 4725 Calle Quetzal Ste B, Camarillo CA 93012-8429
  • 제조사 모회사 (2017)
  • Source
    USFDA