{
  "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": "84151",
      "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": "E-Mail",
      "distribution_pattern": "CO, WA, CA, UT, CA, TN, TX, MS, MO, AR, OK, LA, MN, IL, IN, KY, OH, MI, PA, SC, FL, PR, AL, GA, NM, AZ, NV, VA, RI, MD, ME PA, NY  OUS: None",
      "recall_number": "Z-0611-2020",
      "product_description": "EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in  instrument tray FA EMP PAT TOOL KIT Part # 800-99-096",
      "product_quantity": "410 devices",
      "reason_for_recall": "The firm has received reports/complaints concerning the  breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant prior to impaction, this may cause off axis loading which can increase the risk of device failure. This could cause a delay in surgery. If the tip is not seen during surgery, long term risks may include an inflammatory response, infection, and/ or pain",
      "recall_initiation_date": "20190204",
      "center_classification_date": "20191206",
      "report_date": "20191218",
      "code_info": "All Lots",
      "more_code_info": ""
    }
  ]
}