Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.
FDA device recall Z-1427-2013 · posted 2013-05-29 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Clarification of existing labeling information and operating procedures.
- Action taken
- 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.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- NA
- Distribution
- 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,
- Date initiated
- 2011-09-19
- Date posted
- 2013-05-29
- Date terminated
- 2013-05-30
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 (K050369) | Intuitive Surgical, Inc. | 2005-04-29 |