Device Recall Axle Interspinous Fusion System Torque Driver Handle

  • Model / Serial
    Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including CA, CO, FL, IA, IN, LA, NY, PA, TN, TX and UT.
  • Product Description
    Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 || The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    X Spine Systems Inc, 452 Alexandersville Rd, Miamisburg OH 45342-3658
  • Manufacturer Parent Company (2017)
  • Source
    USFDA