Z-0857-2025Class II
8Mm,resano Forceps,is4000 Ref 470181
Intuitive Surgical, Inc. / initiated 2024-12-19 / Open, Classified
Intuitive Surgical, Inc. began a recall of 8MM,RESANO FORCEPS,IS4000 REF 470181 on . FDA classified it as Class II and gives the reason as "Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-0857-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- 8Mm,resano Forceps,is4000 Ref 470181
- Product code
- NAY System, Surgical, Computer Controlled Instrument
- Reason for recall
- Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- FDA root cause
- Process change control
- Action
- On 12/19/2024, the firm send via email an "Urgent: Medical Device Correction" Letter informing customer that Intuitive Surgical has become aware of an increase in complaints regarding frayed or broken cables on some da Vinci X and Xi reusable instruments. Customer are instructed to: 1. Customers can continue using the products in accordance with the user manual. 2. As a reminder, when using da Vinci X and Xi reusable instruments, follow the Inspection Before Use and Warnings listed in the manual provided with your system to inspect for any broken cables. Refer to Figures C and D for examples. In addition, please refer to Appendix B for additional images for detection of grip cable failures. 3. If you observe any failed (frayed or broken) grip cables prior to use, during procedure, or during reprocessing, please stop use of instrument, remove from use and inform Intuitive via the standard complaint process. 4. Inform Intuitive of any Adverse Events*/Serious Incidents** or quality problems concerning the use of the subject device via the standard complaint process. For Question and assistance - " North and South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: [email protected]. " Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or [email protected] " South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or [email protected] " Japan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) or [email protected] " India: +1-800-103-6952 (9 am to 6 pm IT) " Taiwan: +0800-86-8181 (9 am to 6 pm CT)
- Quantity in commerce
- 373
- 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
- Product codes and lots
- Model Number: 470181 Part Number: 470181-09 UDI-DI code: 00886874112304 Batch Numbers: K10230601 K10230608 K10230824 K10230928 K10231012 K10231027 K10240118 K10240222 K10240516 K10240711 K10240725 K10240801
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0847-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0848-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0849-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0850-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0851-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0852-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0853-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0854-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0855-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0856-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0857-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0858-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0859-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0860-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0861-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0862-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0863-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0864-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0865-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0866-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0867-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0868-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0869-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0870-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0871-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0872-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0873-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0874-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0875-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0876-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0877-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0878-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0879-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0880-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0881-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0882-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0883-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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