{
  "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": "54",
      "code_info": "Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C.    Case Numbers: CSI070314-JF1  CSI082214-EC1  CSI090314-CG1  CSI091614-JB1  CSI101414-RA1  CSI110514-SS2  CSI120814-JC1  CSI121114-DD1  CSI121614-LG1  CSI121714-OL1  CSI011615-AC1  CSI012915-JG1  CSI012915-SS1  CSI022415-HL1  CSI040615-RA1  CSI060115-EB1  CSI102215-CT1  CSI112415-ES1  CSI101615-BE1  CSI012016-RT1B  CSI022916-CS1  CSI032216-SP1  CSI020216-JR1  CSI051716-TM1  CSI070516-AT1  CSI070116-EG1  CSI072816-JE1  CSI092716-AV1  CSI101416-TY1  CSI110816-CS1  CSI112316-NK1  CSI092616-CB1  CSI111516-RB1  CSI113016-NR1  CSI111616-FH1  CSI010517-JH1  CSI041417-KK1  CSI060117-AR1  CSI062617-LV1  CSI071017-NS1A  CSI081717-GG1  CSI081717-JM1  CSI082717-LH1  CSI082917-UK1  CSI081717-JM1  CSI090617-JH2  CSI092717-DH1  CSI092617-OT1  CSI100417-EZ1  CSI100517-AE1  CSI100617-MH1  CSI101817-KD1  CSI102617-NK1  CSI101617-JF1B",
      "center_classification_date": "20180514",
      "distribution_pattern": "US nationwide distribution.",
      "state": "CT",
      "product_description": "Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004",
      "report_date": "20180523",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Kelyniam Global, Inc.",
      "recall_number": "Z-1873-2018",
      "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"
    }
  ]
}