{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "218948",
      "product_res_number": "Z-2524-2026",
      "event_date_initiated": "2026-02-11",
      "event_date_posted": "2026-06-22",
      "recall_status": "Open, Classified",
      "res_event_number": "98509",
      "product_code": "LZD",
      "pma_numbers": [
        "P980052"
      ],
      "product_description": "TMJ Bilateral Implants, REF: CHG020",
      "code_info": "UDI-DI: 07613327626575, Lot: 2508181038",
      "firm_fei_number": "3001237463",
      "recalling_firm": "TMJ Solutions Inc",
      "address_1": "6059 King Dr",
      "city": "Ventura",
      "state": "CA",
      "postal_code": "93003-7607",
      "additional_info_contact": "805-650-3391",
      "reason_for_recall": "Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.",
      "root_cause_description": "Process control",
      "action": "On 2/11/2026, the customer was contacted and verbally informed of the recall.\n\nOn 4/23/2026, a recall notice was sent to the customer asking them to take the following action:\n\n1) Inform all appropriate members of your organization who need to be made aware of this action.\n2) The affected product is already implanted. Following explantation, during revision surgery, the explanted device shall be returned to the firm's sales representative. \n3) Complete and return the Business Reply Form (BRF) via email to cmf-pfa@stryker.com\n\nPlease contact the firm's quality department cmf-pfa@stryker.com with questions or concerns.",
      "product_quantity": "1",
      "distribution_pattern": "US Nationwide distribution in the state of MA.",
      "openfda": {
        "pma_number": [
          "P980052",
          "P000023",
          "P020016"
        ],
        "registration_number": [
          "1529009",
          "1828288",
          "2031049",
          "1450662",
          "1032347",
          "8010177",
          "3010927122",
          "1064858"
        ],
        "fei_number": [
          "3002821504",
          "3008397795",
          "1000149660",
          "1828288",
          "1450662",
          "1032347",
          "3001237463",
          "3010927122"
        ],
        "device_name": "Joint, Temporomandibular, Implant",
        "medical_specialty_description": "Dental",
        "regulation_number": "872.3940",
        "device_class": "3"
      }
    }
  ]
}