8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
Reported: January 22, 2025 Initiated: December 19, 2024 #Z-0923-2025
Product Description
8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
Reason for Recall
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 33,219
- Distribution
- U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY. The countries of Canada, Austria, Belgium, Denmark, Finland, France, French Guiana, Germany, Guadeloupe, Ireland, Luxembourg, Martinique, Monaco, Netherlands, Norway, Reunion, Sweden, Switzerland, United Kingdom, India, Japan, South Korea, Taiwan, Brazil, Argentina, Australia, Bulgaria, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Kuwait, Lebanon, Malaysia, Malta, Mexico, New Zealand, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Thailand, Turkey, United Arab Emirates, Venezuela, Vietnam.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.. Recalled by Intuitive Surgical, Inc.. Units affected: 33,219.
Why was this product recalled? ▼
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2025. Severity: Moderate. Recall number: Z-0923-2025.
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