Medtronic PIN — Class II medical device recall Z-1022-2025
Ongoing recall by Medtronic Navigation, Inc., reported 2025-02-05, distributed nationwide. Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference f
| Recall number | Z-1022-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Lafayette, CO, United States |
| Recall initiated | 2024-12-04 |
| Classified | 2025-01-27 |
| Reported by FDA | 2025-02-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BR, CA, CH, CN, CR, CZ, DE, DK, ES, FI, GB, GT, HK, HU, IE, IL, IN, IT, JO, JP, KR, KW, MA, MX, NL, NO, NZ, PH, PL, PT, RU, SA, SE, SG, SK, TH, TN, TW, VN, ZA |
| Quantity | 67,370 pins |
| UPC / GTIN / UDI-DI | 00613994247865, 00613994247872, 00643169105669, 00643169105676 |
| Lot numbers | 2023071142, 2023071143, 2023071144, 2023080327, 2023080330, 2023091351, 2023091353, 2023091354, 2023091355, 2023091356, 2023091357, 2023091358, 2023091359, 2023091360, 2023100459, 2023100460, 2023101139, 2023101140, 2023101141, 2023101142, 2023101470, 2023101471, 2023101472, 2023101473, 2023110368, 2023110370, 2023110371, 2023110372, 2023110373, 2023110821, 2023110822, 2023110823, 2023110824, 2023111489, 2023111490, 2023111491, 2023111492, 2023120008, 2023120009, 2023120010 and 72 more |
| Model numbers | 9733235, 97733236 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1022-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.