{
  "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": "Ongoing",
      "city": "Austin",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85376",
      "recalling_firm": "Encore Medical, LP",
      "address_1": "9800 Metric Blvd",
      "address_2": "N/A",
      "postal_code": "78758-5445",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution including in the states of MN, VA, IL, IN, SC, N, TX, CA.",
      "recall_number": "Z-1929-2020",
      "product_description": "EMPOWR Acetabular System, Non-Sterile, Model Numbers   803-15-023  803-15-026  803-15-027  803-15-028  803-15-029  803-15-030     Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joint replacement in patients suffering from disability due to noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; rheumatoid arthritis, correction of functional deformity, femoral fracture, and in the salvage of previously failed surgical attempts.",
      "product_quantity": "86 units",
      "reason_for_recall": "The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impaction which could cause debris to migrate or be left in the joint space.",
      "recall_initiation_date": "20191022",
      "center_classification_date": "20200508",
      "report_date": "20200520",
      "code_info": "All lots"
    }
  ]
}