Device Recall SavannahT Rods

  • Modèle / numéro de série
    Part Number 10704-200 Lot Number 124422, 129766, 130739, 132430; Part Number 10704-250 Lot Number 129790, 130738, 131211, 131309, 131310, 131509, 132811; Part Number 10704-300 Lot Number 129862, 134229; Part Number 10704-400 Lot Number 129861, 130145, 130147, 130502, 131499, 131646; Part Number 10704-500 Lot Number 127934, 127937, 129770, 129863, 130130, 130143, 130781, 134228; Part Number 10705-200 Lot Number 122654, 123583, 129773, 130131, 132153, 132154, 132762; Part Number 10705-220 Lot Number 128818, 131311, 132881; Part Number 10705-240 Lot Number 130500; Part Number 10705-260 Lot Number 121521, 131500, 132199; Part Number 10705-280 Lot Number 121519, 130740; Part Number 10705-300 Lot Number 130140, 130332, 134299; Part Number 10706-200 Lot Number 128522, 129567, 129781, 129891, 130741; Part Number 10707-200 Lot Number 128815, 129782, 129783, 129784, 130182, 131410, 132880.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • 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
    Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Number 10704-400; Savannah-T Straight Rod, 500mm; Savannah-T High Top Straight Rod, 200mm; Savannah-T High Top Straight Rod, 220mm, Part Number 1705-220; Savannah-T High Top Straight Rod, 240mm, Product Code 10705-240; Savannah-T Straight Rod, 260mm, Part Number 10705-260; Savannah-T Straight Rod, 280mm, Part Number 10705-280; Savannah-T Straight Rod, 300mm, Part Number 10705-300; Savannah-T Notched Curved Rod, 200mm, Part Number 10706-200; Savannah-T Curve Rod, 200mm, Part Number 10707-200 || 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