Device Recall Tornier Latitude Elbow Prosthesis

  • 모델명 / 제조번호(시리얼번호)
    CC0810047
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including FL and MO
  • 제품 설명
    Latitude", Tige Humerale, Humeral Stem, Medium 77 mm, Humeral Stem Right, For Cemented use only, Sterile R, REF 0030402, Tornier In. Edina, MN 55435 USA. || The Tornier In. Latitude Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using others techniques. The Tornier In. Latitude Elbow Prosthesis is intended for cemented use only.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Tornier, Inc, 7701 France Ave S Ste 600, Edina MN 55435-3202
  • 제조사 모회사 (2017)
  • Source
    USFDA