Device Recall Zimmer

  • 모델명 / 제조번호(시리얼번호)
    lot no.: 61873094 61895696 61905916 61905918 61905920 61919766 61919767 61919768 61956249 61956250 61981202 61981204 61999375 62027331 62060784 62074467 62074469 62096750 62096751 62133740 62164984 62168517 62171693 62171694 62171696 62174936 62205101 62213332 62213333 62220943 62345691 62345692 62345693 62345694 62352447 62352450
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 48 consists of all product under product code: JWH and same usage: || Item no: || 597206526 NEXGEN ALL-POLY PATELLA, || for use in total knee arthroplasty
  • 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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 263 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot P020077.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    The product was shipped to Hawaii, New York, South Carolina, and South Dakota in the United States.
  • 제품 설명
    Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Only the Trinica Bone Tap Instruments are being recalled from the sets.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lots 60244776, 60254445, 60270467, 60278638, 60298344, 60317739, 60330363 and 60342788.
  • 의료기기 분류등급
  • 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
  • 모델명 / 제조번호(시리얼번호)
    Lots 60244777, 60254446, 60259343, 60280558, 60295662, 60298480, 60307612, 60333170 and 60336853.
  • 의료기기 분류등급
  • 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
  • 모델명 / 제조번호(시리얼번호)
    Lots 08686700 and 08686500.
  • 의료기기 분류등급
  • 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
  • 모델명 / 제조번호(시리얼번호)
    Lots 08686600 and 08686800.
  • 의료기기 분류등급
  • 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
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