Device Recall Primary Securfit Plus Max Hip Stem

  • 모델명 / 제조번호(시리얼번호)
    6054-0812S PRIMARY SECUR-FIT PLUS MAX #8/12 72MMME, 6054-0812S PRIMARY SECUR-FIT PLUS MAX #8/12 WA5MLE, 6054-0915S PRIMARY SECUR-FIT PLUS MAX #9/15 11AMME, 6054-1014S PRIMARY SECUR-FIT PLUS MAX #10/14 AKKMME, 6054-1014S PRIMARY SECUR-FIT PLUS MAX #10/14 AKXMME, 6054-1014S PRIMARY SECUR-FIT PLUS MAX #10/14 DHKMME and 6054-1218S PRIMARY SECUR-FIT PLUS MAX #12/18 EP2MME
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
  • 제품 설명
    Primary Secur-fit Plus Max Hip 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