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U.S. Department of Health and Human Services

Class 2 Device Recall Humeral Augmented Tray (HAT) trials

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  Class 2 Device Recall Humeral Augmented Tray (HAT) trials see related information
Date Initiated by Firm May 11, 2021
Create Date June 29, 2021
Recall Status1 Completed
Recall Number Z-1977-2021
Recall Event ID 87989
510(K)Number K191561  
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
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.
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.
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 Nw 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Mr. Nicholas Bennett
800-392-2832
Manufacturer Reason
for Recall		 The HAT trial contains a retaining ring that has shown the potential to disengage during use.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = PHX and Original Applicant = Exactech, Inc
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