Device Recall Maxim

  • 모델명 / 제조번호(시리얼번호)
    Lots 692030, 847270, 893240, 991260, 103470, 103440, 136560, 271330, 170710, 356500, 399630, 399640, 564090, 712190, 744790, 757850, 770410, 994540 and 863650.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide, Australia, Austria, Belgium, Canada, Costa Rica, Denmark, Finland, Greece, Israel, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, and the United Kingdom.
  • 제품 설명
    Biomet Maxim SI knee instruments sliding femoral 4-in-1 block, 60 mm, stainless steel; Ref. RD140530.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 제조사 모회사 (2017)
  • 제조사 의견
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 151 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Catalog No. CL60-100; Known Lot No. NHS160219.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution - US including CA and VA.
  • 제품 설명
    PALLAS M/MAXIMIS Large Crosslink. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog No. CR60-030; Lot No. Unknown.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution - US including CA and VA.
  • 제품 설명
    PALLAS M/MAXIMIS 5.5 x 05mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog No. C060-050; Known Lot No. WNV110516
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution - US including CA and VA.
  • 제품 설명
    PALLAS M/MAXIMIS 50mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog No. C060-060; Known Lot No. WNV110516
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution - US including CA and VA.
  • 제품 설명
    PALLAS M/MAXIMIS 60mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog No. 0902-1007. Unknown Lot No.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution - US including CA and VA.
  • 제품 설명
    PALLAS M/MAXIMIS 5.5 mm Instrument Tap. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
하나 더 146 건 더