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U.S. Department of Health and Human Services

Class 2 Device Recall Crossfire Console

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  Class 2 Device Recall Crossfire Console see related information
Date Initiated by Firm June 28, 2010
Date Posted August 09, 2010
Recall Status1 Terminated 3 on March 21, 2011
Recall Number Z-2193-2010
Recall Event ID 56321
510(K)Number K071859  
Product Classification electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product 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.
Code Information Model number 475-000-000, manufactured between June 2009 and April 2010. All serial numbers are affected.
Recalling Firm/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact
408-754-2124
Manufacturer Reason
for Recall		 RF energy or powered shaver handpieces may continue to operate when not intended when used with the iSwitch Wireless Foot switch.
FDA Determined
Cause 2		 Software design
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 crossfireconsole@stryker.com. 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 crossfireconsole@stryker.com.
Quantity in Commerce 989 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = Stryker Endoscopy
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