Device Recall Legacy 4 Implant

  • 모델명 / 제조번호(시리얼번호)
    Lot #71729
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distribution was made to FL, GA, MD, MI, NC, NY, OR, TX, UT and VA. There was no foreign/military/government distribution.
  • 제품 설명
    ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
  • 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