Device Recall ZMS Intramedullary Fixation Smooth Guide Wire

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  63715690 63780127 63787482
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
  • 제품 설명
    ZMS Intramedullary Fixation Smooth Guide Wire || 2.4 mm Diameter, 100 cm Length; Item Number: 47-2237-033-00
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  63662549 63668704 63696974 63709171 63721377 63731176 63764550 63771164 63781920 63803595 63812302 63817719 63826242
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
  • 제품 설명
    ZMS Intramedullary Fixation Smooth Guide Wire || 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  63645655 63650115 63650116 63655995 63655996 63655997 63655998
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
  • 제품 설명
    ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip || 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-038-00
  • Manufacturer