Z-2193-2010

Crossfire Console, model number 475-000-000, Manufactured by Stryker Endoscopy San Jose Medical device...

Name: Z-2193-2010 Crossfire Console, model number 475-000-000, Manufactured by Stryker Endoscopy San Jose Medical device...
Creator: Stryker Endoscopy
Published: 2010-06-28
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2010-06-28 / Terminated / root cause: software

FDA source

Stryker Endoscopy began a recall of Crossfire Console, model number 475-000-000, Manufactured by Stryker Endoscopy San Jose Medical device indicated for use in orthopedic and arthroscopic... on 2010-06-28. The reason FDA records is "RF energy or powered shaver handpieces may continue to operate when not intended when used with the iSwitch Wireless Foot switch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2193-2010
Status: Terminated
Initiated: 2010-06-28
Posted: 2010-08-09
Terminated: 2011-03-21
Recalling firm: Stryker Corp.
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: RF energy or powered shaver handpieces may continue to operate when not intended when used with the iSwitch Wireless Foot switch.
Root cause tag: software
FDA 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 [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].
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.
Product codes and lots: Model number 475-000-000, manufactured between June 2009 and April 2010. All serial numbers are affected.

Product code GEI

K071859Class IIStryker Crossfire SystemStryker Endoscopy / cleared 2007-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)