{
  "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": "2026-07-08",
    "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": "97048",
      "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": "U.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, and WA",
      "recall_number": "Z-2126-2025",
      "product_description": "Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS  Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE  Model/Catalog Number: 341-12-711  Software Version: NA  Product Description: Enovis\" knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.  Component: NA",
      "product_quantity": "20",
      "reason_for_recall": "Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged.  The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.",
      "recall_initiation_date": "20250602",
      "center_classification_date": "20250717",
      "report_date": "20250723",
      "code_info": "Lot Code: Item: 341-12-711 GTIN: 00888912166980 Lot: 115T1077"
    }
  ]
}