{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "132000",
      "product_res_number": "Z-0521-2015",
      "event_date_initiated": "2014-10-17",
      "event_date_posted": "2014-12-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-01-04",
      "res_event_number": "69644",
      "product_code": "LZD",
      "pma_numbers": [
        "P020016"
      ],
      "product_description": "Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand\nReconstruction of the temporomandibular joint",
      "code_info": "Model 24-6546TI, Lot #s: 526040B, 526050A, 526040A, 526050B.",
      "firm_fei_number": "1032347",
      "recalling_firm": "Biomet Microfixation, LLC",
      "address_1": "1520 Tradeport Dr",
      "city": "Jacksonville",
      "state": "FL",
      "postal_code": "32218-2480",
      "additional_info_contact": "Rachel Osbeck\n904-741-4400",
      "reason_for_recall": "Laser etching on the parts is wider and deeper than the conditions previously validated.",
      "root_cause_description": "Software Design Change",
      "action": "BIOMET sent an Urgent Medical Device Recall letter dated October 17, 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by  the customer.  Customers were instructed to take the following steps: 1) Immediately locate and remove from circulation the items invoiced/consigned/loaned to your account. 2) Carefully follow the instructions on the enclosed \"Response Form.\" and 3)If you have further distributed these items to medical facilities, you must notify them of this action. For questions customers were instructed to call 1-800-874-7711 or 904-741-4400, extension 9448, Monday through Friday, 8 a.m. to 4 p.m. EST.\nFor questions regarding this recall call 904-741-9448.",
      "product_quantity": "42",
      "distribution_pattern": "Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.",
      "openfda": {
        "pma_number": [
          "P020016",
          "P000023",
          "P980052"
        ],
        "device_name": "Joint, Temporomandibular, Implant",
        "medical_specialty_description": "Dental",
        "regulation_number": "872.3940",
        "device_class": "3",
        "registration_number": [
          "2031049",
          "1450662",
          "1529009",
          "1032347",
          "1064858",
          "1828288",
          "3010927122",
          "8010177"
        ],
        "fei_number": [
          "1450662",
          "3008397795",
          "1032347",
          "1828288",
          "3010927122",
          "3002821504",
          "3001237463",
          "1000149660"
        ]
      }
    }
  ]
}