Device Recall Point Setter

  • Model / Serial
    Inddivdual Serial Numbers - 18 total: 70952; 70972; 71002; 71012; 71022; 71032; 71042; 71052; 71062; 71082; 71102; 71112; 71122; 71142; 81162; 81172; 81182; 81192.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AZ, FL, CA, SC, OH, WA, TX, VA, MI, MO, GA, and NC and the country of Canada.
  • Product Description
    Mitaka Point Setter, holding system for surgical instruments. || Holding surgical instruments during operating procedures.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Mitaka USA, Inc., 2337 Lucky John Dr, Park City UT 84060-6914
  • Manufacturer Parent Company (2017)
  • Source
    USFDA