{
  "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": [
    {
      "country": "United States",
      "city": "Gainesville",
      "address_1": "2320 NW 66th Ct",
      "reason_for_recall": "Possibility that the Equinoxe Preserve Humeral  Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather than the  Equinoxe Preserve Humeral Stem IFU as intended .",
      "address_2": "",
      "product_quantity": "40 devices",
      "code_info": "Catalog Number: 300-30-08;    UDI: 10885862515766;    Serial Numbers: 5569566, 5569576, 5569579, 5569582, 5569584, 5569586, 5569589, 5569595.",
      "center_classification_date": "20190226",
      "distribution_pattern": "US Nationwide distribution in the states of  AL,FL, IA, LA, MD, OH, SC.",
      "state": "FL",
      "product_description": "Equinoxe Preserve Humeral Stem, 8mm    Product Usage:  The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total arthroplasty,anatomic hemi-arthroplasty,or reverse total arthroplasty is determined by the surgeon to be the preferred method of treatment. The Equinoxe Preserve Stems are additionally indicated for use in reverse total arthroplasty in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff or a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Equinoxe Preserve Stems are intended for press-fit applications but may be used with bone cement at the discretion of the surgeon.",
      "report_date": "20190306",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Exactech, Inc.",
      "recall_number": "Z-0958-2019",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "82025",
      "termination_date": "20210429",
      "more_code_info": "",
      "recall_initiation_date": "20181205",
      "postal_code": "32653-1630",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}