FDA Device recall Z-1977-2021
Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a…
- FDA Device
- Class II
- completed
- Published 2021-07-07
On 2021-07-07 the FDA classified a Class II recall of Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a… by Exactech, citing the HAT trial contains a retaining ring that has shown the potential to disengage during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1977-2021 |
| Classification | Class II |
| Status | completed |
| Initiated | 2021-05-11 |
| Published | 2021-07-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Exactech |
| Distribution | US |
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
The HAT trial contains a retaining ring that has shown the potential to disengage during use.
Identifiers
| code_info | (1) HAT STD Left Tray Trial, Lot #279244001, UDI 10885862541239 ; (2) HAT STD Right Tray Trial, Lot #279244002, UDI 108…(1) HAT STD Left Tray Trial, Lot #279244001, UDI 10885862541239 ; (2) HAT STD Right Tray Trial, Lot #279244002, UDI 10885862541246 ; (3) HAT LAT Left Tray Trial, Lot #279244017, UDI 10885862541253; (4) HAT LAT Right Tray Trial, Lot #279244004, UDI 10885862541260; (5) HAT EXT LAT Left Trial, Lot #279244005, UDI 10885862541277; and (6) HAT EXT LAT Right Trial, Lot #279244006, UDI 10885862541284. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1977-2021%22
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