Z-1022-2025 Class II Ongoing
FDA device recall Z-1022-2025 was initiated by Medtronic Navigation, Inc. on December 4, 2024 and is designated Class II. Reason for recall: Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter. The recall status is ongoing. Affected quantity: 67,370 pins.
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2025
- Initiation Date
- December 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 67,370 pins
Product Description
Reason for Recall
Distribution Pattern
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.