Exactech, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1977-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 11, 2021

Date Posted: July 7, 2021

Recall Number: Z-1977-2021

Event ID: 87989

Reason for Recall:

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

Status: Completed

Product Quantity: 36 devices

Code Information:

(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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated