{
  "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": "178035",
      "product_res_number": "Z-0691-2020",
      "event_date_initiated": "2019-11-04",
      "event_date_created": "2019-12-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-05-05",
      "res_event_number": "84320",
      "product_code": "KYJ",
      "k_numbers": [
        "K082231"
      ],
      "product_description": "Ascension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage:  \nThe Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.",
      "code_info": "Lot Number: Lot 192715T",
      "firm_fei_number": "3001700044",
      "recalling_firm": "Integra Lifesciences Sales Llc",
      "address_1": "311 Enterprise Dr",
      "city": "Plainsboro",
      "state": "NJ",
      "postal_code": "08536-3344",
      "additional_info_contact": "Dr. Patricia Kihn\n717-309-3966",
      "reason_for_recall": "Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant",
      "root_cause_description": "Labeling mix-ups",
      "action": "Integra notified by letter consignee via courier service, facsimile or email  between November 4th and 6th, 2019, advising reason for recall, health risk and action to take: confirm that the device was actually implanted as part of the above-referenced surgery and, if so, please confirm the date of that surgery.\n2. Complete the attached Acknowledgement Form and return the completed form by email or fax indicating receipt and review of this notification. Keep a copy of the form for your records.\n\nShould you have any questions regarding these instructions, please contact Customer Service Monday to Friday 8:00 AM  8:00 PM EST\nUSA: 1-800-654-2873: email: custsvcnj@integralife.com\nOutside USA: 781-565-1401",
      "product_quantity": "9 units",
      "distribution_pattern": "US Nationwide distribution in the state of CA.",
      "openfda": {
        "k_number": [
          "K781380",
          "K001922",
          "K233670",
          "K870200",
          "K082231",
          "K022892",
          "K211385",
          "K931588",
          "K140453",
          "K220142",
          "K013629",
          "K083107",
          "K970544",
          "K781668"
        ],
        "registration_number": [
          "1020279",
          "3007366790",
          "1818910",
          "1226544",
          "1221934",
          "3010372554",
          "3015239144",
          "3008395366",
          "3002894438",
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          "3024706750",
          "3014596751",
          "2031009",
          "1000286794",
          "3002807310"
        ],
        "fei_number": [
          "1020279",
          "3003128516",
          "3007282753",
          "1000116116",
          "1818910",
          "1221934",
          "3010372554",
          "3015239144",
          "3008395366",
          "3002894438",
          "3000718490",
          "3003477135",
          "3016669046",
          "3008868758",
          "3024706750",
          "3014596751",
          "1000286794",
          "3002807310",
          "1000306340",
          "3001236812"
        ],
        "device_name": "Prosthesis, Finger, Constrained, Polymer",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3230",
        "device_class": "2"
      }
    }
  ]
}