Device Recall Incise Zirconia Coping (CBZR0102)

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 97646, 97415, 97418, 97422, 97417 97421, 97420, 97481, 97423, 97419, 97488, 97476, 97478, 97486 97490, 97416.
  • 의료기기 분류등급
  • 의료기기 등급
    Not Classified
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) and the country of Canada.
  • 제품 설명
    "***3i Incise Custom-Made Label. QP157 Approved 07/09/10*** 3i inc se Custom-made Dental Framework***Biomet 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 800-342-5454 www.biomet3i.com Please consult instructions for use and recommendation***For Dental Lab use ONLY Non-sterile/For single Use***" || Indicated for use in restorative procedure to affix the final prosthesis to the abutment. Coping and frameworks provide the base structure for final porcelain application as the final step of creating a restoration. The devices are intended to be used to create final restoration for dental reconstruction with either a prepared tooth or dental implant abutment.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Biomet 3i, LLC, 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
  • 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