{
  "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": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "64941",
      "recalling_firm": "Stryker Howmedica Osteonics Corp.",
      "address_1": "325 Corporate Drive",
      "address_2": "N/A",
      "postal_code": "07430",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide distribution: USA including states of: HI, IN, MS, NC, NJ, OK, TX, and WI.",
      "recall_number": "Z-1370-2013",
      "product_description": "Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package    Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA     Stryker France, ZAC Satolas Green Pusignan, Av de Satoles Green 69881  Meyzieu, Cedex, France    This device is used when there is a deficiency in the bone present during femoral preparation these devices are used to \"fill the gap\" between the implant and the bone",
      "product_quantity": "11 units",
      "reason_for_recall": "Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathalon Femoral Distal Augment 10mm- Size 5 Left depicted a glyph of an acetabular shell rather than a femoral distal augment.  In addition the label was missing a reference to the \"10mm\" augment thickness which per the label print is required to appear below the size reference.",
      "recall_initiation_date": "20130325",
      "center_classification_date": "20130523",
      "termination_date": "20150506",
      "report_date": "20130529",
      "code_info": "Catalog Number 5541-A-501  Lot Codes HALY, HAOO, HANG"
    }
  ]
}