BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2193-2010 · Initiated June 28, 2010

    Recall

    Recall Number
    Z-2193-2010
    Event Number
    56321
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 28, 2010
    Posted
    August 9, 2010
    Terminated
    March 21, 2011
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    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.

    Reason

    RF energy or powered shaver handpieces may continue to operate when not intended when used with the iSwitch Wireless Foot switch.

    Action

    Stryker Endoscopy sent an "Urgent: Device Correction" letter dated June 28, 2010, via FedEX Mailer to US customers. A letter dated July 9, 2010, was sent to International sites.The letter describes the product, problem, and action to be taken by customers. The Customers were instructed to follow the included instructions and use the USB dongle to install the correction and to complete and sign the enclosed "acknowledgement of receipt" form,upon completion of the software correction, and fax to (480) 754-8378 or scan in and email to [email protected]. The firm noted that-It is important to send the self addressed confirmation forms back to Stryker RAQA. If you have any questions regarding this letter, please contact us by phone at 1-800-624-4422 or via email at [email protected].

    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.

    Quantity

    989 units