{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "West Chester",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63230",
      "recalling_firm": "Synthes USA HQ, Inc.",
      "address_1": "1302 Wrights Ln E",
      "address_2": "N/A",
      "postal_code": "19380-3417",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution including CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.",
      "recall_number": "Z-0396-2014",
      "product_description": "Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502    Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.",
      "product_quantity": "745",
      "reason_for_recall": "This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening.  Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations.",
      "recall_initiation_date": "20120907",
      "center_classification_date": "20131126",
      "termination_date": "20151218",
      "report_date": "20131204",
      "code_info": "All lots"
    }
  ]
}