{
  "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": "23",
      "code_info": "Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C.    Case Numbers: CSI111715-KH1  CSI072814-JB1  CSI082514-MA1  CSI080714-CT1  CSI091914-JW1  CSI101614-TR1  CSI041415-MZ1  CSI100915-DD1  CSI120215-MM1  CSI100915-DD2  CSI011816-TA1  CSI012016-RT1A  CSI012716-MP1  CSI021116-CA1  CSI030716-BC1  CSI040716-CK1  CSI060916-DF1  CSI070716-AC1  CSI092116-JA1  CSI110416-DW1  CSI120616-LS1  CSI012417-SD1  CSI062617-HR1",
      "center_classification_date": "20180514",
      "distribution_pattern": "US nationwide distribution.",
      "state": "CT",
      "product_description": "Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003",
      "report_date": "20180523",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Kelyniam Global, Inc.",
      "recall_number": "Z-1872-2018",
      "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"
    }
  ]
}