Humeral Augmented Tray — Class II medical device recall Z-1977-2021
Completed recall by Exactech, Inc., reported 2021-07-07, distributed nationwide. The HAT trial contains a retaining ring that has shown the potential to disengage during use.
| Recall number | Z-1977-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2021-05-11 |
| Classified | 2021-06-29 |
| Reported by FDA | 2021-07-07 |
| Distributed | Nationwide (US) |
| Quantity | 36 devices |
| UPC / GTIN / UDI-DI | 10885862541239, 10885862541246, 10885862541253, 10885862541260, 10885862541277, 10885862541284 |
| Lot numbers | 279244001, 279244002, 279244004, 279244005, 279244006, 279244017 |
| Model numbers | 321-00-01, 321-00-02, 321-00-11, 321-00-12, 321-00-21, 321-00-22 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1977-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.