Device Recall LOCATOR Implant Attachment System

  • 모델명 / 제조번호(시리얼번호)
    Part Numbers: 8875-SPI, 8875-SPI-TMS, 8876-SPI, 8876-SPI-TMS, 08877-SPI, 08877-SPI-TMS, 08878-SPI, 08878-SPI-TMS, 08879-SPI, 08880-SPI; Lot Numbers: 11052, 15306, 20665, 21351, 12025,12259, 22440, I0K7X, I0K7Y, 11963,15307,17676,18934, 25294, 25567, I0JQ7, 12258,12941,15000, 19735, 20666, I0K7Z, I0KY7, 12703, 14568, 19832, 22170, I0LCG, 11093, 13364, 14151, 15624, 20043, 25026, 13530, I0LE4, 10055, 14152, 15001, 25027, 10892, 10893.   Since the LOCATOR¿ Implant Attachment System (including the restorative components) is not sold by the Zest Anchors as a sterilized product, it does not have a designated shelf-life.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distributed in Ohio and Switzerland.
  • 제품 설명
    LOCATOR¿ Implant Attachment System. || The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. || FDA 510(k): K994257, K072878
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zest Anchors LLC, 2061 Wineridge Pl, Escondido CA 92029-1947
  • Source
    USFDA