Equinoxe recallZ-1977-2021 · Exactech, Inc. · initiated May 11, 2021
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Exactech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The HAT trial contains a retaining ring that has shown the potential to disengage during use.
FDA root cause category: Device Design
What the company is doing
The firm issued letters dated 5/11/2021 explaining the issue, the clinical impact, and instructing the consignee to immediately cease distribution or use of the product. The information was to be extended to their accounts who may have the product in their possession.
Recall details
- Recall number
- Z-1977-2021
- Status
- Completed
- Initiated by the company
- May 11, 2021
- Recalling firm
- Exactech, Inc.
- Quantity
- 36 devices
- Product code
- PHX
- FDA submissions
- K191561
- Distribution
- US Nationwide distribution in the states of AZ, CO, FL, NY, SC, and TN. There was no foreign/government/military distribution.
Product description
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.
Code information (models, lots, serial numbers)
(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.
Devices named in this recall
6 devices in the FDA device registry whose identifier appears in the recall's code information.
- Equinoxe 321-00-02Exactech, Inc. · Shoulder Prosthesis, Reverse Configuration1 recall1 report
- Equinoxe 321-00-12Exactech, Inc. · Shoulder Prosthesis, Reverse Configuration1 recall1 report
- Equinoxe 321-00-01Exactech, Inc. · Shoulder Prosthesis, Reverse Configuration1 recall0 reports
- Equinoxe 321-00-11Exactech, Inc. · Shoulder Prosthesis, Reverse Configuration1 recall0 reports
- Equinoxe 321-00-21Exactech, Inc. · Shoulder Prosthesis, Reverse Configuration1 recall0 reports
- Equinoxe 321-00-22Exactech, Inc. · Shoulder Prosthesis, Reverse Configuration1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K191561 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Equinoxe 320-05-21Exactech, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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