Device Recall Crossfire Console

  • Model / Serial
    Model number 475-000-000, manufactured between June 2009 and April 2010. All serial numbers are affected.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries including Australia, France, Germany, Greece, South Africa, Iberia, Italy, New Zealand, Poland, UK, Switzerland, Canada, China, Japan and the EMEA.
  • Product Description
    Crossfire Console, model number 475-000-000, Manufactured by Stryker Endoscopy San Jose || Medical device indicated for use in orthopedic and arthroscopic procedures for the knee, shoulder, ankle, elbow, wrist and hip. The system provides abrasion, resection, debridement, and removal of bone and soft tissue through its shaver blade and ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its electrosurgical probe. Examples of use include resection, ablation and coagulation of torn knee cartilage, subacromial decompression and resection of synovial tissue in other joints. The probe is contraindicated for use in procedures where a nonconductive irrigant is used or with patients having cardiac pacemakers or other electronic implants.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Manufacturer Parent Company (2017)
  • Source
    USFDA