Device Recall OMNIFLEX MHA HIP STEM SERIES

  • 모델명 / 제조번호(시리얼번호)
    Product number: 6046-0425, Lot 24897301 and Product number: 6046-0830, Lot 24352201.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Omniflex-HA Hip Stem W/C Taper. || Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
  • Manufacturer
  • 1 Event

제조사

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