# FDA recall Z-0414-2018

> **Exactech, Inc.** · Class II · device recall initiated 2017-08-31.

## Product

Equinoxe Cage, Glenoid, Alpha, Small    Product Usage:  The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.

## Reason for recall

Potentially mislabeled.

## Distribution

Worldwide distribution in the states of OH, WI, AZ, GA, VA, CA, OK, MN, TN, ME, CO, SC, FL, AL, and Puerto Rico  and country of Switzerland

## Key facts

- **Recall number:** Z-0414-2018
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-31
- **Report date:** 2018-02-07
- **Termination date:** 2019-08-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gainesville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0414-2018

## Citation

> AI Analytics. FDA recall Z-0414-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0414-2018. Source: US FDA. Licensed CC0.

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