Device Recall Syneture Surgilon

  • 모델명 / 제조번호(시리얼번호)
    Lot Code Number:  D1D0288X
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • 제품 설명
    Syneture Surgilon 5/0 Blk 5X18 T-37/CV-20 D-TACH || non-absorbable braided nylon sutures || Material 8886191022 || Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Covidien LP, 60 Middletown Ave, North Haven CT 06473-3908
  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 8 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot Code Number:  D1C0200G D1C0662GX
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • 제품 설명
    Syneture Sofsilk 2/0 30" BLACK V-20 DT || non-absorbable braided nylon sutures || GS66M || Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Code Number: D1C0077 D1C0274 D1A0463
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • 제품 설명
    Syneture Sofsilk 0 18" BLACK GS-21 DT || non-absorbable braided nylon sutures || CS10M || Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Code Number:  D1C0213
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • 제품 설명
    Syneture Sofsilk 3/0 BK 12X18" PRE-CUT WAX-RACE || non-absorbable braided nylon sutures || S194 || Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Code Number:  D1C0270
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • 제품 설명
    Syneture Sofsilk 0 BLACK 6X 18" PRE-CUT WAX/RACE || non-absorbable braided nylon sutures || S196 || Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Code Number:  D1C0245X D1C0292X D1D0257X D1B0584X
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • 제품 설명
    Syneture Surgilon 0 Blk 3X18 CE-10/C-16 || non-absorbable braided nylon sutures || Material 8886193662 || Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue.
  • Manufacturer
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