FDA Medical Device Recalls (openFDA)
Stryker Endoscopy: 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 number
- Z-2193-2010
- Recalling firm
- Stryker Endoscopy
- 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.
- Status
- Terminated
- Initiated
- 2010-06-28
- Posted
- 2010-08-09
- Terminated
- 2011-03-21
- Reason
- RF energy or powered shaver handpieces may continue to operate when not intended when used with the iSwitch Wireless Foot switch.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- Model number 475-000-000, manufactured between June 2009 and April 2010. All serial numbers are affected.
- 510(k) numbers
- ["K071859"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 2936485
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28