FDA-Device2025-02-05Class II
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a patient reference during image-guided surgeries using a Medtronic computer-assisted surgery system.
Medtronic Navigation, Inc.
Hazard
Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.
Sold states
Worldwide - 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, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, China, Costa Rica, Czech Republic, Denmark, Finland, Germany, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Arab Emirates, United Kingdom, Vietnam.
Affected count
67,370 pins
Manufactured in
200 Medtronic Dr, Lafayette, CO, United States
Products
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a patient reference during image-guided surgeries using a Medtronic computer-assisted surgery system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1022-2025Don't want to check this manually?
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