Device Recall KyphX Osteo Introducer System

  • Model / Serial
    Lot code J8052810
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Class II Recall - Nationwide Distribution.
  • Product Description
    KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the KyphoPak Tray, First Fracture, 15/3 Xpander), catalog number KPT1502, manufactured by Medtronic Spine LLC. Device is used to access vertebral body during balloon kyphoplasty, a procedure designed to reduce and stabilize vertebral body compression fractures (VCFS).
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Kyphon Inc, 1221 Crossman Ave, Sunnyvale CA 94089-1103
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA