{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Plainsboro",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79597",
      "recalling_firm": "Integra LifeSciences Corp.",
      "address_1": "311 Enterprise Dr",
      "address_2": "N/A",
      "postal_code": "08536-3344",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) Distribution.",
      "recall_number": "Z-1463-2018",
      "product_description": "The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling:    Catalog Number\tProduct Description  TRL092002506\tHumeral Stem Trial, 6mm  TRL092002507\tHumeral Stem Trial, 7mm  TRL092002508\tHumeral Stem Trial, 8mm  TRL092002509\tHumeral Stem Trial, 9mm  TRL092002510\tHumeral Stem Trial, 10mm  TRL092002511\tHumeral Stem Trial, 11mm  TRL092002512\tHumeral Stem Trial, 12mm  TRL092002513\tHumeral Stem Trial, 13mm  TRL092002514\tHumeral Stem Trial, 14mm  TRL092002515\tHumeral Stem Trial, 15mm  TRL092002516\tHumeral Stem Trial, 16mm",
      "product_quantity": "1619 units",
      "reason_for_recall": "Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or trialing. All cases resulted in a delay in surgery, with a variance of medical intervention required.",
      "recall_initiation_date": "20171220",
      "center_classification_date": "20180420",
      "termination_date": "20200224",
      "report_date": "20180502",
      "code_info": "TRL092002506   Lot Numbers:  19419-1  15916-1  15457-1  201274-1  201893-1  2046177    TRL092002507  Lot Numbers:  19419-2  15916-2  15457-2  201274-2  201893-2  2046178    TRL092002508  Lot Numbers:  19419-3  15916-3  15457-3  201274-3  201893-3  2046179    TRL092002509  Lot Numbers:  19419-4  15916-4  15457-4  201274-4  201893-4  20461710    TRL092002510  Lot Numbers:  19419-5  15916-5  15457-5  201274-5  201893-5  20461711    TRL092002511  Lot Numbers:  19419-6  15916-6  15457-6  201274-6  201893-6  20461712    TRL092002512   Lot Numbers:  19419-7  15916-7  15457-7  201274-7  201893-7  20461713    TRL092002513  Lot Numbers:  19419-8  15916-8  15457-8  201274-8  201893-8  20461714    TRL092002514   Lot Numbers:  19419-9  15916-9  15457-9  201274-9  201893-9  20461715    TRL092002515  Lot Numbers:  19419-10  15916-10  15457-10  201274-10  201893-10  20461716    TRL092002516  Lot Numbers:  19419-11  15916-11  15457-11  201274-11  201893-11  20461717"
    }
  ]
}