# FDA recall Z-0459-2021

> **Exactech, Inc.** · Class II · device recall initiated 2020-10-06.

## Product

Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium

## Reason for recall

The product may be mislabeled.

## Distribution

US consignees - AZ, CA, CO, FL, IL, IN, KY, LA, OH, OK, MD, ME, MN, NV, NY, SC, TN, TX, VA, WA, WI    International consignees - Australia, Japan, and United Kingdom

## Key facts

- **Recall number:** Z-0459-2021
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-06
- **Report date:** 2020-11-25
- **Termination date:** 2023-11-13

- **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-0459-2021

## Citation

> AI Analytics. FDA recall Z-0459-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-0459-2021. Source: US FDA. Licensed CC0.

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