Home / Recalls / Intuitive Surgical, Inc. / Z-2059-2023

Z-2059-2023 Class II Ongoing

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
July 12, 2023
Initiation Date
June 12, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
46,033

Product Description

da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12

Reason for Recall

Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of PR, FL, MN, PA, AZ, OH, IL, NC, GA, KS, CA, HI, MD, OR, SC, AK, NY, NE, IA, WA, OK, ND, UT, MS, AR, WI, MI, TX, TN, IN, NJ, VA, SD, CO, KY, AL, MO, LA, DE, MA, MT, WV, ID, CT, NV, NH, ME, WY, DC, RI, NM, VT and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Mexico, Monaco, Netherlands, Norway, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom.

Code Information

UDI-DI: 00886874112496, All Lots.

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