Device Recall Ascent

  • 모델명 / 제조번호(시리얼번호)
    Lots 074170, 117920, 117580, 170730, 191880, 232930, 439220, 409710, 441190, 468560, 523310, 608390, 602560, 024500, 278400 and 840090.
  • 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 Ascent SI knee instruments sliding femoral 4-in-1 block, small, stainless steel; Ref. RD140630.
  • 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 6 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lots 147360, 201140, 310920, 238700, 238710, 397060, 467290, 481540, 523300, 607880, 024490, 560790 and 761870.
  • 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 Ascent SI knee instruments sliding femoral 4-in-1 block, x-small, stainless steel; Ref. RD140629.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lots 061800, 300150, 191900, 192030, 542470, 439240, 443030, 481530, 608400, 024540, 278410 and 761860.
  • 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 Ascent SI knee instruments sliding femoral 4-in-1 block, medium, stainless steel; Ref. RD140631.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lots 061810, 217860, 170830, 195550, 467300, 481550, 450420, 602570, 608410, 576640, 024590, 388080 and 840080.
  • 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 Ascent SI knee instruments sliding femoral 4-in-1 block, large, stainless steel; Ref. RD140632.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lots 117650, 170870, 229660, 238680, 467310, 491720, 608420, 542570, 491721, 024600, 351170 and 561190.
  • 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 Ascent SI knee instruments sliding femoral 4-in-1 block, x-large, stainless steel; Ref. RD140633.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Part Numbers: 65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330; Lot numbers: 009, 010, 011, 018, 019, 031, 048, 064, 084 and 107.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide: USA and countries of China, Cyprus, Turkey and Switzerland.
  • 제품 설명
    Ascent POCTS (Posterior Occipital Cervical Thoracic System) Part Numbers: 65-33 XX Series (65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330), Multi-Axial Screw, 4.0mm x 26mm;Implant grade Titanium Alloy; Blacksone Medical Inc., 90 Brookdale Drive, Springfield, MA 01104.
  • Manufacturer
하나 더 1 건 더