Device Recall BioHorizons 0.050 Handpiece Hex Driver

  • Modèle / numéro de série
    Lot Number 11060189
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- USA and countries of Canada, Norway, Australia, Spain, Brazil, Pakistan, Israel, Latvia, Japan, Columbia, Thailand, Turkey, Italy, South Korea, India, Taiwan, Ukraine, Russia, United Arab Emirates, Saudi Arabia, Hong Kong, Romania, UK, Kuwait, and Lithuania
  • Description du dispositif
    BioHorizons 0.050 Hex Driver, Regular, REF 134-350, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only. The product is part of a Prosthetic Instrumentation system Kit 51-K , Manufactured by Innovision, Inc., and the kits are assembled by BioHorizons.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    BioHorizons Implant Systems Inc, One Perimeter Park South, Suite 230, South, Birmingham AL 35243
  • Source
    USFDA