Intuitive Surgical, Inc.: 8MM,MEGA SUTURECUT ND,IS4000 REF 471309

Hazard

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Details from the source

Reason for recall: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. 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, Ok Quantity: 88,840 Lot/code info: 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 K11240

UPC codes

00886874119815

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.