Device Recall MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPORTitaniumBarrier (MTB) Right

  • 모델명 / 제조번호(시리얼번호)
    Part Number 81036; Lot Number A1402020, A1405060
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US Nationwide in the states of PA, KY, VA, CT, UT, MD, AR, FL, TX, AL, DE, IL, IA, MI, CO, OH, GA, CA, DC, MO, LA, WI, ID, SC, NC, NY, MA, NH, CA, OK, MN, KY, IN, OR, TN and the countries of: Argentina, Australia, Canada, Chile, China, Netherlands, France, Spain, South Korea, Colombia, Switzerland, Singapore, and South Africa.
  • 제품 설명
    MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right || Product Usage: || MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Stryker Craniomaxillofacial Division, 750 Trade Centre Way, Ste 200, Portage MI 49002-0482
  • 제조사 모회사 (2017)
  • Source
    USFDA