{
  "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": "141618",
      "product_res_number": "Z-0367-2016",
      "event_date_initiated": "2015-10-26",
      "event_date_posted": "2015-12-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-05-08",
      "res_event_number": "72591",
      "product_code": "MIX",
      "k_numbers": [
        "K060815"
      ],
      "product_description": "PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.",
      "code_info": "Lot Number  100079214, 100077099, 100077251, 100077252, 100077253, 100078692, 100079598, 100080204, 100081409, 100081577, 100082304, 100082438, 100083371, 100083875, 100083932",
      "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 were issued 11/4/2015 to consignees.  The letter informs the consignees that they can continue to safely use the affected products by referring to the USE BEFORE date.  They letter does not require for any product to be returned. Also, there is no sub-recall required as the product was not distributed to distributors or wholesalers.",
      "product_quantity": "7,715 units",
      "distribution_pattern": "Distributed US (nationwide) including the Virgin Islands and South Africa.",
      "openfda": {
        "k_number": [
          "K080956",
          "K070090",
          "K972317",
          "K000533",
          "K121795",
          "K060815",
          "K240919",
          "K001466",
          "K150400",
          "K071663",
          "K983525",
          "K033398",
          "K081815",
          "K081816",
          "K180631",
          "K083783",
          "K011554"
        ],
        "registration_number": [
          "3002647932",
          "1037007",
          "3003790304",
          "1450662",
          "3013840437",
          "3011050570",
          "1928237",
          "3007225376",
          "1219795",
          "2135225"
        ],
        "fei_number": [
          "3002647932",
          "1037007",
          "3003790304",
          "1450662",
          "3013840437",
          "3011050570",
          "3003407669",
          "1928237",
          "3007225376",
          "1219795"
        ],
        "device_name": "System, Vocal Cord Medialization",
        "medical_specialty_description": "Ear, Nose, Throat",
        "regulation_number": "874.3620",
        "device_class": "2"
      }
    }
  ]
}