{
  "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": "97188",
      "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 in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.",
      "recall_number": "Z-2285-2025",
      "product_description": "Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704   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.",
      "product_quantity": "18 implants",
      "reason_for_recall": "Knee implants contain incorrect labeling (size and/or side incorrect)",
      "recall_initiation_date": "20250709",
      "center_classification_date": "20250808",
      "report_date": "20250820",
      "code_info": "Lot Code: Item: 341-16-704 GTIN: 00888912167116 Lot\\s: 148T1057",
      "more_code_info": ""
    }
  ]
}