{
  "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": [
    {
      "status": "Terminated",
      "city": "Laval",
      "state": "N/A",
      "country": "Canada",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "70630",
      "recalling_firm": "Pega Medical Inc.",
      "address_1": "1111 Autoroute Chomedy",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution in the states of: California, Florida, New York, and Puerto Rico (US).",
      "recall_number": "Z-1362-2015",
      "product_description": "GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM.  Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28.    Product Usage:  The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and humerus of pediatric patients, who have reached skeletal maturity. The GAP Nail is an intramedullary nail. It is the main component of the GAP Endo-Exo Medullary System. The rest of the components of the system are screws, plates and caps that are assembled to the nail during the surgical procedure. The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of: long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP System is used for pediatric patients (child and adolescent) ages 2 to 21. It can be used to correct the following conditions: -Diaphyseal fracture of the femur, tibia and humerus -Fractures of the femoral neck -Subtrochanteric, intertrochanteric and combination fractures -Correction of deformities (OI, Coxa vara, Coxa valga) -Nonunions and malunions",
      "product_quantity": "7 units distributed in the US;",
      "reason_for_recall": "Failures of the 4.8mm of the GAP Endo-Exo Medullary System have been identified at the level of the distal cortical screw holes. Failures mainly occurred in patients with tibial pseudoarthrosis (CPT) or Osteogenesis imperfecta (OI).  Higher failure rates have been detected in tibias with distal fractures that are close to the distal locking holes.",
      "recall_initiation_date": "20150220",
      "center_classification_date": "20150401",
      "termination_date": "20150430",
      "report_date": "20150408",
      "code_info": "Lot numbers: 110913-001; 110913-002; 110913-004; 110913-005;"
    }
  ]
}