—#117854

Product

Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K050369
Affected lot / code info: Model number 420002-07

Why it was recalled

Clarification of existing labeling information and operating procedures.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

Intuitive Surgical sent an "IMPORTANT PRODUCT NOTIFICATION" letter dated October 17, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Customer Service at 1-800-876-1310 for questions regarding this notice.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 100, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.

Timeline

Recall initiated: 2011-09-19
Posted by FDA: 2013-05-29
Terminated: 2013-05-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #117854. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.