Z-1977-2021Class II

Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the...

Name: Z-1977-2021 Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the...
Creator: Exactech, Inc.
Published: 2021-05-11
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2021-05-11 / Completed / root cause: design

FDA source

Exactech, Inc. began a 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 total of 6... on 2021-05-11. FDA classified it as Class II and gives the reason as "The HAT trial contains a retaining ring that has shown the potential to disengage during use". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-1977-2021
Classification: Class II
Status: Completed
Initiated: 2021-05-11
Posted: 2021-06-29
Recalling firm: Exactech, Inc.
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.
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: The HAT trial contains a retaining ring that has shown the potential to disengage during use.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 36 devices
Distribution: US Nationwide distribution in the states of AZ, CO, FL, NY, SC, and TN. There was no foreign/government/military distribution.
Product codes and lots: (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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1977-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1977-2021	Class II	Completed	Voluntary: Firm initiated	2021-07-07	2021-06-29

Product code PHX

K191561Class IIExactech Equinoxe Humeral Augmented TraysExactech, Inc. / cleared 2019-08-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)