Device Recall Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES

  • 모델명 / 제조번호(시리얼번호)
    a) REF 6975205, 5mm; UDI 00643169752979 Lot Number ID17K018 b) REF 6975206, 6mm; UDI 00643169752962  Lot Number ID17J009 c) REF 6975207, 7mm; UDI 00643169752955 Lot Numbers: ID17K007, ID17L035
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: || a) REF 6975205, 5mm || b) REF 6975206, 6mm || c) REF 6975207, 7mm || Product Usage: || The PRESTIGE LP reusable instruments are intended for the surgical implantation of the PRESTIGE LP Cervical Disc. Medtronic reusable instruments must be sterilized prior to initial use and must be cleaned and sterilized prior to each re-use.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Pl, Memphis TN 38132-1703
  • 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