# FDA recall Z-0291-2018

> **Orthofix Srl** · Class II · device recall initiated 2017-07-05.

## Product

Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box.    Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.

## Reason for recall

The power drill torque limiter may break during use in surgery application.

## Distribution

Worldwide Distribution -- US, including the states of CA, FL, & PA; and, the countries of Australia, Germany, Finland, France, Italy, Lithuania, Netherlands, Singapore, South Africa, Sweden, Switzerland, & United Kingdom.

## Key facts

- **Recall number:** Z-0291-2018
- **Recalling firm:** Orthofix Srl
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-05
- **Report date:** 2018-01-03
- **Termination date:** 2023-01-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bussolengo, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0291-2018

## Citation

> AI Analytics. FDA recall Z-0291-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0291-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*