Device Recall Armstrong Grommet

  • Model / Serial
    Lot #: 147809
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including CA, and GERMANY.
  • Product Description
    Armstrong Grommet with wire Otological Ventilation Tube || Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. || Intended to provide ventilation to the middle ear space through the tympanic membrane.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Summit Medical, Inc., 815 Northwest Pkwy Ste 100, Eagan MN 55121-1658
  • Source
    USFDA