8MM,MEGA SUTURECUT ND,IS4000 REF 471309
FDA Recall #Z-0880-2025 — Class II — December 19, 2024
Product Description
8MM,MEGA SUTURECUT ND,IS4000 REF 471309
Reason for Recall
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Recalling Firm
Intuitive Surgical, Inc. — Sunnyvale, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
88,840
Distribution
U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam
Code Information
Model Number: 471309 Part Number: 471309-15 UDI-DI code: 00886874119815 Batch Numbers: K10221113 K10221115 K10221212 K10221218 K10230103 K10230112 K10230122 K10230124 K10230129 K10230205 K10230212 K10230219 K10230720 K10230824 K10240621 K10240718 K11221113 K11221115 K11221212 K11230103 K11230112 K11230122 K11230202 K11230212 K11230217 K12221113 K12221212 K12230112 K12230122 K12230205 K12230217 K13221113 K13230217 K14230217 K15230217 K16240508 K16240531 U10230217 U10230223 Model Number: 471309 Part Number: 471309-16 UDI-DI code: 00886874119815 Batch Numbers: K10230302 K10230310 K10230316 K10230323 K10230330 K10230413 K10230420 K10230427 K10230504 K10230509 K10230511 K10230518 K10230525 K10230601 K10230608 K10230615 K10230622 K10230630 K10230706 K10230713 K10230727 K10230803 K10230810 K10230817 K10230831 K10230913 K10230914 K10230921 K10231005 K10231012 K10231019 K10231027 K10231102 K10231109 K10231123 K10231130 K10231207 K10231218 K10240104 K10240111 K10240118 K10240125 K10240215 K10240222 K10240229 K10240308 K10240314 K10240321 K10240322 K10240411 K10240418 K10240425 K10240502 K10240516 K10240523 K10240530 K10240606 K10240613 K10240614 K10240619 K10240711 K10240718 K10240822 K11230302 K11230310 K11230316 K11230323 K11230330 K11230413 K11230420 K11230511 K11230518 K11230601 K11230615 K11230706 K11230713 K11230727 K11230803 K11230810 K11230817 K11230913 K11230914 K11230921 K11231005 K11231012 K11231019 K11231027 K11231102 K11231109 K11231123 K11231130 K11231207 K11231218 K11240104 K11240111 K11240118 K11240125 K11240229 K11240308 K11240314 K11240321 K11240322 K11240411 K11240418 K11240502 K11240516 K11240523 K11240530 K11240606 K11240613 K11240711 K11240718 K11240822 K12230302 K12230310 K12230316 K12230323 K12230413 K12230420 K12230706 K12230810 K12230914 K12230921 K12231005 K12231012 K12231027 K12231109 K12231116 K12231123 K12231130 K12240104 K12240111 K12240118 K12240125 K12240321 K12240411 K12240418 K12240502 K12240516 K12240523 K12240530 K12240606 K12240613 K13230323 K13230914 K13231012 K13231027 K13231109 K13231116 K13240104 K13240111 K13240118 K13240125 K13240502 K13240523 K13240530 K13240606 K14240104 K14240111 K14240125 K14240523 U10230420 U10230426 U10230502 U10230522 U10230630 U10230707 U10230714 U10230824 U10230901 U10230914 U10231016 U10231103 U10231115 U10231120 U11230326 U11230418 U11230707 U11230824 U11230901 U11230914 U11231016 U11231020 U11231103
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.