# FDA recall Z-0572-2025

> **Gauthier Biomedical, Inc.** · Class II · device recall initiated 2024-11-11.

## Product

TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm,  Model Number 5161-00-5048 (G919509)

## Reason for recall

An out of specification component may result in the device exhibiting torque output higher than the design specification.

## Distribution

US Nationwide distribution in the state of MA.

## Key facts

- **Recall number:** Z-0572-2025
- **Recalling firm:** Gauthier Biomedical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-11
- **Report date:** 2024-12-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grafton, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0572-2025

## Citation

> AI Analytics. FDA recall Z-0572-2025. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-0572-2025. Source: US FDA. Licensed CC0.

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