Device Recall Innovasis Excella II Standard

  • 모델명 / 제조번호(시리얼번호)
    E2S47525 Lot 1301 and E2S47535 Lot 1301
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
  • 제품 설명
    Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Innovasis, Inc, 614 E 3900 S, Salt Lake City UT 84107-1902
  • 제조사 모회사 (2017)
  • Source
    USFDA