Device Recall Aesculap

  • 모델명 / 제조번호(시리얼번호)
    4 lots: 4505268906, 4505336973, 4505408485, 4505238953
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US Distribution including the states of AZ, MD, MA, WI, MI, MN, DE, KS, and FL., and the countries of Australia, Germany, Great Britain, Norway and Japan.
  • 제품 설명
    Aesculap proSA Adjustment Disc Size Large (L) || The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
  • Manufacturer
  • 1 Event

제조사

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 10 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    material numbers: FV400T FV401T FV402T FV403T FV404T FV405T FV406T FV407T FV408T FV409T FV499T FV790T FV791T FV792T FV793T FV794T FV795T FV796T
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US Nationwide
  • 제품 설명
    Miethke Shunt System accessories || Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Item # FH620R
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed throughout the United States and Canada.
  • 제품 설명
    AESCULAP MINOP InVent 30 Trocar System, non-sterile || Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    All distributed lot numbers and serial numbers
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution, including the states of CA, CO, IL, LA, NV, OH, and TX .
  • 제품 설명
    S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    4 degree - SJ768T-US and 9 degree SJ780T-US
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution - including the states of CO, OH, OK and TX.
  • 제품 설명
    Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) || Product Usage: || The Aesculap Implant Systems SIBD Trial Implant instruments assist the surgeon in selecting the correct size implant for the patient
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    All distributed lots and serial numbers
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution-including the states of IL, MN, NV, OK, and TX.
  • 제품 설명
    Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). || The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities: 1 - degenerative disc disease, 2 - spondylolisthesis, 3 - trauma, 4 - spinal stenosis, 5 - deformities or curvatures, 6 - tumor, 7 - pseudoarthrosis, and 8 - failed previous fusion.
  • Manufacturer
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