# FDA recall Z-1126-2019

> **ulrich medical USA Inc** · Class II · device recall initiated 2019-03-08.

## Product

ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.

## Reason for recall

Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.

## Distribution

AZ, IL, LA, MI, MO, NV, OH, PA, TN, and TX.

## Key facts

- **Recall number:** Z-1126-2019
- **Recalling firm:** ulrich medical USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-08
- **Report date:** 2019-04-17
- **Termination date:** 2020-07-10

- **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-1126-2019

## Citation

> AI Analytics. FDA recall Z-1126-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1126-2019. Source: US FDA. Licensed CC0.

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