Recall Z-1977-2021 ยท PHX Shoulder Prosthesis, Reverse Configuration
Exactech, Inc.
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
| Date | May 11, 2021 |
| Status | Completed |
| Reason | The HAT trial contains a retaining ring that has shown the potential to disengage during use. |
| 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 | 36 devices |
| Distribution | US Nationwide distribution in the states of AZ, CO, FL, NY, SC, and TN. There was no foreign/government/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191561 | Exactech Equinoxe Humeral Augmented Trays Exactech, Inc., Aug 20, 2019 |