{
  "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": [
    {
      "country": "United States",
      "city": "Ventura",
      "address_1": "2233 Knoll Dr",
      "reason_for_recall": "This device was mislabeled and is not the correct component for this patient.",
      "address_2": "",
      "product_quantity": "1",
      "code_info": "Lot: W43963, Serial T170939RM, UDI +B004TYYNNNNRM0/$$3191101W43963/ST170939RMF",
      "center_classification_date": "20180419",
      "distribution_pattern": "US Distribution to GA.",
      "state": "CA",
      "product_description": "Patient-Fitted Temporomandibular (TMJ) Right  Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM    The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the temporomandibular joint. It is indicated for patients with one or more of the following conditions: Inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment; Recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment; Failed tissue graft; Failed alloplastic joint reconstruction; Loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion",
      "report_date": "20180425",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "TMJ Solutions Inc",
      "recall_number": "Z-1444-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "79614",
      "termination_date": "20190723",
      "more_code_info": "",
      "recall_initiation_date": "20180312",
      "postal_code": "93003-7398",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}