Device Recall Mini MaxTorque HCS05632 Drivers

  • Model / Serial
    HSC-056-38-1067061
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: USA including the states of CA, CO, FL, GA, IL, MO, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA, and WI.
  • Product Description
    OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS || The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Orthohelix Surgical Designs Inc, 1065 Medina Rd., Suite 500, Medina OH 44256
  • Manufacturer Parent Company (2017)
  • Source
    USFDA