Device Recall Reunion HA Fracture Stem

  • 모델명 / 제조번호(시리얼번호)
    R5351-4507 REUNION HA FRACTURE STEM 7MM T2T72836-J, R5351-4508 ReUnion HA Fracture Stem 8MM T2N71522-I, R5351-4508 ReUnion HA Fracture Stem 8MM T2T72422-C and R5351-4509 REUNION HA FRACTURE STEM 9MM T2N71523-G
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
  • 제품 설명
    Reunion HA Fracture Stem || These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430
  • 제조사 모회사 (2017)
  • Source
    USFDA