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.
FDA Recall Z-2193-2010 · Posted 2010-08-09
Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeGEI
Date Initiated2010-06-28
Date Terminated2011-03-21
Product Quantity989 units
Reason for Recall
RF energy or powered shaver handpieces may continue to operate when not intended when used with the iSwitch Wireless Foot switch.
Firm 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].
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.