Z-2059-2023 Class II Ongoing
FDA device recall Z-2059-2023 was initiated by Intuitive Surgical, Inc. on June 12, 2023 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 46,033.
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
Reason for Recall
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.