Devices

Device Recall ECT Internal Fracture Fixation Drill

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 63556698, 63630276, 63630277, 63358163, 63364072,  63372863, 63415324, 63415327, 63426481, 63457812, 63457820,  63457825, 63469937, 63469939, 63474431, 63474432, 63474433, 63524435 & 63524436.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • 제품 설명
    ECT Internal Fracture Fixation Drill 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802700, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
  • 1 Event

제조사

Zimmer Biomet, Inc.
  • 제조사 주소
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 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

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Device Recall ECT Internal Fracture Fixation Drill
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 63574373, 63622721, 63398756, 63415316, 63444654, 63462301, 63474169, 63485122, 63485126, 63496894, 63505359, 63530405 & 63530406
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • 제품 설명
    ECT Internal Fracture Fixation Drill 1.1 mm Diameter (.043 Inch), Item Number/EDI 00231801100, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ECT Internal Fracture Fixation Drill Bits
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 63562129, 63578148, 63377521, 63398755, 63415317, 63431736, 63438195, 63438272, 63444661, 63462322, 63474385, 63485128, 63497202, 63505360, 63510813, 63524432 & 63530407.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • 제품 설명
    ECT Internal Fracture Fixation Drill Bits 1.1 mm Diameter, Item Number/EDI 00231801106, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ECT Internal Fracture Fixation Drill
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 63610789, 63610790, 63333727, 63340530, 63364066, 63364067, 63384623, 63398757, 63431747, 63444664, 63444666, 63444667, 63444668, 63462334, 63462340, 63474387, 63485135, 63485138, 63485141, 63497203, 63497204, 63507361 & 63540409
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • 제품 설명
    ECT Internal Fracture Fixation Drill 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801500, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ECT Internal Fracture Fixation Drill Bits
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 63545279, 63610791, 63641572, 63333729, 63333730, 63333732, 63340531, 63364064, 63364065, 63372902, 63384626, 63384629, 63444670, 63444671, 63457776, 63457945, 63462343, 63462344, 63474390, 63497205, 63497206, 63505362, 63510815, 63535517, 63535518 & 63722007.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • 제품 설명
    ECT Internal Fracture Fixation Drill Bits 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801506, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ECT Internal Fracture Fixation Drill
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 63545283, 63578152, 63578153, 63584052, 63358182, 63358184, 63364075, 63384616, 63384617, 63384618, 63398734, 63398735, 63415287, 63415288, 63426487, 63426488, 63431725, 63431730, 63438313, 63438315, 63438316, 63438318, 63444673, 63444674, 63444676, 63444677, 63444678, 63444680, 63444681, 63469895, 93468987, 63469898, 63469901, 63499636, 63499638, 63499640, 63499641, 63510882, 63510883, 63510884, 63510885, 63524433, 63535519 & 63535520.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • 제품 설명
    ECT Internal Fracture Fixation Drill 2.0 mm Diameter (.079 Inch), Item Number/EDI 00231802000, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
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