{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "141612",
      "product_res_number": "Z-0366-2016",
      "event_date_initiated": "2015-10-26",
      "event_date_posted": "2015-12-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-05-08",
      "res_event_number": "72585",
      "product_code": "LMH",
      "pma_numbers": [
        "P050052/SO52"
      ],
      "product_description": "Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1.  Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.",
      "code_info": "Lot No. 100083189",
      "firm_fei_number": "1012187",
      "recalling_firm": "Merz North America, Inc.",
      "address_1": "6501 Six Forks Rd",
      "city": "Raleigh",
      "state": "NC",
      "postal_code": "27615-6515",
      "additional_info_contact": "866-862-8211",
      "reason_for_recall": "The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.",
      "root_cause_description": "Other",
      "action": "Letters dated 11/4/2015 were sent to customers with tracking and delivery confirmation.  The letter informs the customer that they may continue to safely use the affected product by referring to the USE BEFORE date.",
      "product_quantity": "1,616 units",
      "distribution_pattern": "Nationwide Distribution including the states of AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, LA, MD, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WI.",
      "openfda": {
        "pma_number": [
          "P030032",
          "P170002",
          "P020012",
          "P050037",
          "P070013",
          "P090016",
          "P140029",
          "P800022",
          "P160042",
          "P050033",
          "P240008",
          "P850053",
          "P030050",
          "P020023",
          "P250016",
          "P110033",
          "P240022",
          "P050047",
          "P250020",
          "P050052",
          "P040024",
          "P250021"
        ],
        "registration_number": [
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          "3031983053",
          "9710154",
          "3009882464",
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          "3007093114",
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          "3031983053",
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        ],
        "device_name": "Implant, Dermal, For Aesthetic Use",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}