Devices

Device Recall Zimmer

  • 모델명 / 제조번호(시리얼번호)
    lot no62240860 62339639 62395853 62240859 62279765 62339640 62395852 62089508 62094969 62185962 62240862 62273366 62279766 61660149 62279769 62284368 62284368N 62284371 62093453
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 12 consists of all product under product code JDI || , and same usage: || Item no: || 902602935 6 DEGREE COCR FEM HEAD 28 || 902602835 6 DEGREE COCR FEM HEAD 28 || 902603235 6 DEGREE COCR FEM HEAD 32 || 902603335 6 DEGREE COCR FEM HEAD 32 || 902603600 6 DEGREE COCR FEM HEAD 36 || 902603610 6 DEGREE COCR FEM HEAD 36 || 902603614 6 DEGREE COCR FEM HEAD 36 || Product Usage: || For use in total or hemi hip arthroplasty
  • Manufacturer
    Zimmer Manufacturing B.V.
  • 1 Event

제조사

Zimmer Manufacturing B.V.
  • 제조사 주소
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 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 Zimmer MIS
  • 모델명 / 제조번호(시리얼번호)
    Lots 60244776, 60254445, 60270467, 60278638, 60298344, 60317739, 60330363 and 60342788.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • 제품 설명
    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 45 degrees, non-sterile; Part number 00-7712-035-01.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer MIS
  • 모델명 / 제조번호(시리얼번호)
    Lots 60244777, 60254446, 60259343, 60280558, 60295662, 60298480, 60307612, 60333170 and 60336853.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • 제품 설명
    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; Part number 00-7712-035-02.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer M/L
  • 모델명 / 제조번호(시리얼번호)
    Lots 08686700 and 08686500.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • 제품 설명
    Zimmer M/L Taper Rasp Handle, Left, 45 degrees, non-sterile; Part number 83-7712-035-01. Recall Z-0671-06 extended to include this product.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer M/L
  • 모델명 / 제조번호(시리얼번호)
    Lots 08686600 and 08686800.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • 제품 설명
    Zimmer M/L Taper Rasp Handle, Right, 45 degrees, non-sterile; Part number 83-7712-035-02. Recall Z-0671-06 extended to include this product.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer M/DN Intramedullary Fixation
  • 모델명 / 제조번호(시리얼번호)
    Lots 14865700, 17308800, 17733600, 17733700, 19001400, 24543400 and 25105000.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide, including USA, Argentina, Brazil, Canada, China, England, France, Germany, Guatemala, Israel, Japan, Jordan, Lebanon, Poland, Saudi Arabia, Singapore, Spain, Taiwan, UAE.
  • 제품 설명
    Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head, 75 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-75-42 (00225307542).
  • Manufacturer
    Zimmer Inc.
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