{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Collinsville",
      "address_1": "97 River Rd",
      "reason_for_recall": "Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to FDA for marketing clearance. The Temporal Suture System (TSS) is no longer being offered and the Integrated Fixation System (IFS) has been temporarily suspended",
      "address_2": "",
      "product_quantity": "16",
      "code_info": "Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C.    Case Numbers: CSI082114-CT1  CSI081214-TB1  CSI020216-LK1  CSI092016-LD1R  CSI100116-BM1A  CSI092616-YB1  CSI092616-MM1  CSI112316-YB1  CSI050217-LS1  CSI052217-AF1  CSI062317-GM1  CSI071017-NS1B  CSI071417-CM1  CSI102617-DL1  CSI101617-JF1A  CSI102617-DL1",
      "center_classification_date": "20180514",
      "distribution_pattern": "US nationwide distribution.",
      "state": "CT",
      "product_description": "Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002",
      "report_date": "20180523",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Kelyniam Global, Inc.",
      "recall_number": "Z-1871-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "79791",
      "termination_date": "20200914",
      "more_code_info": "",
      "recall_initiation_date": "20170610",
      "postal_code": "06019-3246",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}