Device Recall Dual Stylet Needle

  • Model / Serial
    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
  • Product Classification
  • Device Class
    1
  • Implanted device?
    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
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Amendia, Inc, 1755 W Oak Pkwy, Marietta GA 30062-2260
  • Manufacturer Parent Company (2017)
  • Source
    USFDA