Device Recall Tapered ScrewVent Implant

  • 모델명 / 제조번호(시리얼번호)
    Lot No. 62659204, 62658448
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-US (nationwide) and the countries of Poland, Canada, Belgium, Italy, France, Israel, Morocco, Spain, Costa Rica, and Japan.
  • 제품 설명
    Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform || Part No. TSV4B10 || Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm Platform || Part No. TSV4B11 || The Tapered Screw-Vent Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer Dental Inc, 1900 Aston Ave, Carlsbad CA 92008-7308
  • 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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  • 모델명 / 제조번호(시리얼번호)
    Catalog Number TSVWB11, Lot 62470008.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Thailand, Japan, Hong Kong, Morocco, and UAE.
  • 제품 설명
    Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. || Class II, 510(k) K13227.
  • Manufacturer