Device Recall Zimmer

  • 모델명 / 제조번호(시리얼번호)
    lot no.: 62208147 62208146 62208148 62042715 62042716
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 40 consists of all product under product code: HSB and same usage: || Item no: || 225706565 ITST ANTI-ROTATION SCREW || 225707065 ITST ANTI-ROTATION SCREW || 225708065 ITST ANTI-ROTATION SCREW || 225708565 ITST ANTI-ROTATION SCREW || 225709065 ITST ANTI-ROTATION SCREW || Product Usage: || An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 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

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데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lots 61219397, 61228025 and 61277887.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and United Kingdom.
  • 제품 설명
    Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, standard, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-00. || The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot 61221481.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and United Kingdom.
  • 제품 설명
    Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, tall, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-05. || The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot 61291761.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and United Kingdom.
  • 제품 설명
    Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, standard, 0.512" wide, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-10. || The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lots 61161115, 61170213, 61219945, 61256543, 61233590 and 61256542.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and United Kingdom.
  • 제품 설명
    Zimmer Natural Nail System, Tibial Targeting Guide Handle, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-005-00. || The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lots 61161122, 61175552, 61217393, 61248664 and 61233593.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and United Kingdom.
  • 제품 설명
    Zimmer Natural Nail System, Tibial Targeting Guide Handle, tall, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-005-03. || The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.
  • Manufacturer
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