{
  "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": "Plainsboro",
      "address_1": "311 Enterprise Dr",
      "reason_for_recall": "As a result of an internal investigation of a non-conformance it has been determined: 1) Depth Gauges from Lot UP15H2 exceed the overall length specification requirements. 2) Depth Gauges from prior lot numbers manufactured before Integra acquired the product line reflect an incorrect number for the first mm depth marking on the gauge.  The number should be \u00184\u0019, it is \u00186\u0019.   3) The space / holder",
      "address_2": "",
      "product_quantity": "71 units",
      "code_info": "Lot UP15H2, Lot UP09D3, Lot UP07E2",
      "center_classification_date": "20160614",
      "distribution_pattern": "US Distribution to states of: CO, FL, IL, MI, NJ, NY, SC, TX, and VA.",
      "state": "NJ",
      "product_description": "TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws    The FS2030 Depth Gauge is used by the physician to determine the correct screw length when implanting a 2.0 or 2.5mm TS Series screw for the Ti6 Internal Fixation System.",
      "report_date": "20160622",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Integra LifeSciences Corp.",
      "recall_number": "Z-1965-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "74114",
      "termination_date": "20161216",
      "more_code_info": "",
      "recall_initiation_date": "20160510",
      "postal_code": "08536-3344",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}