# FDA recall Z-1022-2025

> **Medtronic Navigation, Inc.** · Class II · device recall initiated 2024-12-04.

## Product

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.

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-1022-2025
- **Recalling firm:** Medtronic Navigation, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-04
- **Report date:** 2025-02-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lafayette, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1022-2025

## Citation

> AI Analytics. FDA recall Z-1022-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1022-2025. Source: US FDA. Licensed CC0.

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