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.
Recall
- Recall Number
- Z-1977-2021
- Event Number
- 87989
- Firm
- Exactech, Inc.
- FEI Number
- 1038671
- Product Code
- PHX
- Status
- Completed
- Root Cause
- Device Design
- Initiated
- May 11, 2021
- Address
- 2320 Nw 66th Ct, Gainesville, FL, 32653-1630
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.
The HAT trial contains a retaining ring that has shown the potential to disengage during use.
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.
US Nationwide distribution in the states of AZ, CO, FL, NY, SC, and TN. There was no foreign/government/military distribution.
36 devices