—#187594

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.

FDA product code: PHX — Shoulder Prosthesis, Reverse Configuration
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K191561
Affected lot / code info: (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.

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 Nw 66th Ct, Gainesville, Florida 32653-1630

Distribution

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

Timeline

Recall initiated: 2021-05-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187594. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.