Device Recall Dual Stylet Needle

  • Modèle / numéro de série
    Part Number 812-11R-15 Lot Number 121945, 123231, 124146, 125418, 126822, 127868, 128459, 128464, 130818, 131492, 13496, 132594, 132813, 134514, 134515, 134517, 134909, 135290, 137302
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to AL, AZ, AR, CA, CO, FL, GA, IA, KS, KY, LA, MA, MI, MN, MO, NV, NJ, NC, SC, TN, TX, VA, WA, WV, WI and Puerto Rico
  • Description du dispositif
    Dual Stylet Needle, Part Number 812-11R-15 || The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Amendia, Inc, 1755 W Oak Pkwy, Marietta GA 30062-2260
  • Société-mère du fabricant (2017)
  • Source
    USFDA