8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033
FDA Recall #Z-0851-2025 — Class II — December 19, 2024
Product Description
8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033
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
1,111
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: 470033 Part Number: 470033-09 UDI-DI code: 00886874112229 Batch Numbers: K10230219 K10230316 K10230511 K10230615 K10230706 K10230713 K10230824 K10230928 K10231005 K10231109 K10231218 K10240104 K10240229 K10240418 K10240613 Part Number: 470033-11 UDI-DI code: 00886874112229 Batch Number: K10230914
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated