Z-0860-2025 Class II Ongoing

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
January 22, 2025
Initiation Date
December 19, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,162

Product Description

8MM,TENACULUM FORCEPS,IS4000¿ REF 470207

Reason for Recall

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

Distribution Pattern

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: 470207 Part Number: 470207-10 UDI-DI code: 00886874112366 Batch Numbers: K10221218 K10230108 K10230205 K10230212 K10230226 K10230302 K10230310 K10230316 K10230323 K10230420 K10230427 K10230504 K10230511 K10230518 K10230525 K10230601 K10230608 K10230615 K10230706 K10230713 K10230803 K10230810 K10230928 K10231005 K10231109 K10231123 K10231130 K10240104 K10240111 K10240119 K10240208 K10240215 K10240222 K10240314 K10240321 K10240411 K10240417 K10240502 K10240509 K10240613 K10240620 K10240815 K10240822 K11230108 K11230817 K11230928 K11231116 K11231123 K11240119 K12231123