Ulrich medical neon3 OCT spinal stabilization — Class II medical device recall Z-1350-2020
Terminated recall by ulrich medical USA Inc, reported 2020-03-04, distributed in AR, AZ, CA, FL, GA, TX. Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably
| Recall number | Z-1350-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ulrich medical USA Inc, Chesterfield, MO, United States |
| Recall initiated | 2019-12-31 |
| Classified | 2020-02-24 |
| Reported by FDA | 2020-03-04 |
| Terminated | 2025-11-17 |
| Distributed | AR, AZ, CA, FL, GA, TX |
| Quantity | 179 units |
| Lot numbers | U010577, U016620, U019084 |
| Model numbers | 3917-12 |
Product
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
Reason for recall
Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation.
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-1350-2020. 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.