# FDA recall Z-1757-2018

> **Tornier, Inc** · Class II · device recall initiated 2018-03-26.

## Product

AEQUALIS HUMERAL NAIL DRILL  BIT, REF 7020140    Product Usage:  The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).

## Reason for recall

Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1757-2018
- **Recalling firm:** Tornier, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-26
- **Report date:** 2018-05-16
- **Termination date:** 2021-08-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1757-2018

## Citation

> AI Analytics. FDA recall Z-1757-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1757-2018. Source: US FDA. Licensed CC0.

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