# FDA recall Z-1350-2020

> **ulrich medical USA Inc** · Class II · device recall initiated 2019-12-31.

## 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.

## Distribution

AZ, TX, GA, FL, AR, CA

## Key facts

- **Recall number:** Z-1350-2020
- **Recalling firm:** ulrich medical USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-31
- **Report date:** 2020-03-04
- **Termination date:** 2025-11-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chesterfield, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1350-2020

## Citation

> AI Analytics. FDA recall Z-1350-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1350-2020. Source: US FDA. Licensed CC0.

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