CLASS II Device recall · Reported 7 Jul 2021 · FDA Enforcement Report

Humeral Augmented Tray (HAT) trials that are components recalled

Exactech is recalling Humeral Augmented Tray (HAT) trials that are components, distributed nationwide in the US. The recall was initiated on 11 May 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes(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.

Quantity recalled36 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1977-2021
FDA event ID: 87989
Recalling firm: Exactech, Gainesville, FL
Classification: Class II
Status: Completed
Recall initiated: 11 May 2021
FDA classified: 29 Jun 2021
Reported: 7 Jul 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

11 May 2021	Recall initiated by company
29 Jun 2021	Classified by FDA	+49 days
7 Jul 2021	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Arizona Colorado Florida New York South Carolina Tennessee

Questions about this recall

Is Humeral Augmented Tray (HAT) trials that are components recalled?

Yes. Exactech recalled Humeral Augmented Tray (HAT) trials that are components on 11 May 2021. The recall is Class II and its status is Completed. Recall number Z-1977-2021.

Why was it recalled?

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

Which lots are affected?

(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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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