Device Recall Arsenal Spinal Fixation System

  • Model / Serial
    671949 681640 684646 687843 690206 692720 693064 671948 681641 684646 687843 690206 692705 674136 681642 684647 687847 690210 692718 674137 682061 686374 687847 691848S1 692719 674431 682060 684645 689847 691848 692855 674432 682062 686372 689847 691849 692855 674433 682063 686375 689849 692597 692706 671950 684429 687839 690127 692597 692864 674429 684430 687839 689848 692364 692910 674430 684432 687840 690207 692598 692911 681638S1 684644 687840 690207 691590 692911 681638 684433 687842 690208 692599 693065 681639 684431 687845 690209 692704 693057
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide in the states of (TX, AL, UT, FL, IA, SD, NV, OH, CA, MN, CO, AZ, OK, MI, VA, KY, and Puerto Rico) and country of Japan
  • Product Description
    Arsenal Spinal Fixation System, Set Screw, Part No. 47027 || Product Usage: || The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELl). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6AI-4V ELl, and Co-28Cr-6Mo).
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Alphatec Spine, Inc., 5830 El Camino Real, Carlsbad CA 92008-8816
  • Manufacturer Parent Company (2017)
  • Source
    USFDA