Device Recall GoDirect

  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 29707, 29708, 29709, 32444, 37438, 38159, 39506, 40394, 40542, 44661, 46030, 50644, 50824, 51092, 51249, 52798, 54274, 54275, 54617, 55407,60158
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - Nationwide Distribution to the states of : FL, AZ, IL, MS, TX, CA, ID, AL, MO, MN, NY, CO, GA, ME, NJ, NC, NV, LA, KS, MN, KY, PA, UT, OH, MI, SC, MD, WA, WI., and to the countries of : Canada, Honduras and Dominican Republic.
  • 제품 설명
    The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. || GoDirect Implants || Part Number: 423011, 423013, 424708, 424710, 424713,433010,433710
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Implant Direct Sybron Manufacturing, LLC, 3050 E Hillcrest Dr, Westlake Village CA 91362-3171
  • 제조사 모회사 (2017)
  • Source
    USFDA