Device Recall Sequoia Spinal System Surgical Kits

  • Model / Serial
    Part Numbers: 3300-0001-PL and 3300-0002-PL.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including states of AR, AZ, CA, CT, CO, FL, IL, MD, MI, MN, NC, OH, OK, OR, PA, TX, VA and WI.
  • Product Description
    Sequoia Spinal System Surgical Kits; Pedicle screw spinal system; Non-sterile (kits intended to be sterilized prior to use); Rx Only; || The Sequoia Spinal System is designed to aid in the surgical correction of several types of spinal conditions. The product is a system of smaller devices used to provide stabilization during the development of a solid fusion mass.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Abbott Spine, 12708 Riata Vista Cir # B-100, Austin TX 78727-7167
  • Source
    USFDA