Device Recall Accolade HFx

  • 모델명 / 제조번호(시리얼번호)
    6077-0230 Accolade HFx Size #2 8XAMLE, 6077-0230 Accolade HFx Size #2 8XEMLE, 6077-0335 Accolade HFx Size #3 8PAMME, 6077-0435 Accolade HFx Size #4 8PEMME, 6077-0435 Accolade HFx Size #4 PJLMLE and 6077-0435 Accolade HFx Size #4 R27MLE
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
  • 제품 설명
    Accolade HFx || 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