{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "Gainesville",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87989",
      "recalling_firm": "Exactech, Inc.",
      "address_1": "2320 Nw 66th Ct",
      "address_2": "N/A",
      "postal_code": "32653-1630",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of AZ, CO, FL, NY, SC, and TN.  There was no foreign/government/military distribution.",
      "recall_number": "Z-1977-2021",
      "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_quantity": "36 devices",
      "reason_for_recall": "The HAT trial contains a retaining ring that has shown the potential to disengage during use.",
      "recall_initiation_date": "20210511",
      "center_classification_date": "20210629",
      "report_date": "20210707",
      "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."
    }
  ]
}