{
  "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": "66420",
      "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.",
      "recall_number": "Z-0388-2014",
      "product_description": "Synthes Tensioning Device     The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.",
      "product_quantity": "369",
      "reason_for_recall": "All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release, nor the device to apply tension.",
      "recall_initiation_date": "20130731",
      "center_classification_date": "20131125",
      "termination_date": "20150601",
      "report_date": "20131204",
      "code_info": "all lots of model number 03.311.001:     Part # Synthes lot #        03.311.001 1934765  03.311.001 1934766  03.311.001 1993844  03.311.001 3036688  03.311.001 3398576  03.311.001 3776484  03.311.001 5100597  03.311.001 5106354  03.311.001 5160872  03.311.001 5160875  03.311.001 5174253  03.311.001 5174253  03.311.001 5174254  03.311.001 5181000  03.311.001 5181001  03.311.001 5196282  03.311.001 5196283  03.311.001 5197081  03.311.001 5241942  03.311.001 5241943  03.311.001 5336723  03.311.001 5363637  03.311.001 5396016  03.311.001 5411479  03.311.001 5555521"
    }
  ]
}