# FDA recall Z-1977-2021

> **Exactech, Inc.** · Class II · device recall initiated 2021-05-11.

## Product

Humeral Augmented Tray (HAT) trials that are components of  KIT-321HAT.  Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray:    (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tray Trial, Cat. #321-00-11; (4) HAT LAT Right Tray Trial, Cat. #321-00-12; (5) HAT EXT LAT Left Trial, Cat. #321-00-21; and (6) HAT EXT LAT Right Trial, Cat. #321-00-22.      The Humeral Augmented Tray is designed to function with the Equinoxe Reverse Shoulder System orthopedic implant components.

## Reason for recall

The HAT trial contains a retaining ring that has shown the potential to disengage during use.

## Distribution

US Nationwide distribution in the states of AZ, CO, FL, NY, SC, and TN.  There was no foreign/government/military distribution.

## Key facts

- **Recall number:** Z-1977-2021
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2021-05-11
- **Report date:** 2021-07-07

- **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-1977-2021

## Citation

> AI Analytics. FDA recall Z-1977-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1977-2021. Source: US FDA. Licensed CC0.

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