Intuitive Surgical, Inc.: 8MM, POTTS SCISSORS, IS4000 REF 470001

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: 3,625 Lot/code info: Model Number: 470001 Part Number: 470001-09 UDI-DI code: 00886874112120 Batch Numbers: K10230308 K11230308 K10230517

UPC codes

00886874112120

Source

Official record: FDA (Device enforcement) ↗

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