Stryker SmartLife Large Aseptic Housing

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    HSAHSA

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데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Manufacture Start Date for Affected Lots: 18-Mar-2015 Manufacture End Date for Affected Lots: 31-Jan-2017
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Domestic: None Foreign: France, Germany
  • 제품 설명
    Stryker SmartLife Large Aseptic Housing (7126-120-000)
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Stryker Instruments-Kalamazoo: Stryker SmartLife Large Aseptic Housings
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Part Number 7126-120-000; All lot numbers from 13027 to 14093
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) WI, MD, NY, NM, AZ, GA, CA, MN, DE, PA, TX, MT, MI, KS, KY, WY, IL; and countries of: Australia, Canada, Sweden, Netherlands, France Switzerland, India, Japan, Poland, South Africa, England, and Hong Kong.
  • 제품 설명
    Stryker SmartLife Large Aseptic Housing || REF 7126-120-000 || Rx Only || The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Handpiece.
  • Manufacturer
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