{
  "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": "2026-04-15",
    "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": "77801",
      "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": "Nationwide Distribution",
      "recall_number": "Z-0067-2018",
      "product_description": "Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS  Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures",
      "product_quantity": "9848 units",
      "reason_for_recall": "Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.",
      "recall_initiation_date": "20170626",
      "center_classification_date": "20171106",
      "report_date": "20171115",
      "code_info": "Lot Numbers:  189690, 189760, 199180, 424740, 508240, 560290, 595660, 638280, 786630, 959650, 959700"
    }
  ]
}