Device Recall Titanium Surfix Alpha Screws

  • Modèle / numéro de série
    Model #295214S, Part #295214SND, Batch #EGH9
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution, USA - including the states of OH, FL, WI, CT, OK, TN, OR, ID, CA, PA, MD, VA, FL, MS, NJ, LA, IA, GA, AL, MA, NY, MN, TN, IL, AR, NE, AZ, MI, WA, OR, NC, KY, MO, UT, NV, IN, SC, CO and the countries of the United Kingdom, France, Switzerland, and Austria.
  • Description du dispositif
    Titanium SURFIX ALPHA SCREWS, a component of the Newdeal Hallu Lock Plate System. Surfix Alpha Variable angle locking system exists in different diameters and lengths. The product can be sold as a replenishment part individually packaged sterile, or as one (1) unit which is kitted within an instrumentation tray at which point, the product is non-sterile until the tray in which it is kitted is sterilized a the designated facility. The product is indicated for use in fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint.
  • Manufacturer
  • 1 Event

Fabricant