{
  "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": "2026-05-06",
    "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": "63442",
      "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": "Worldwide Distribution.",
      "recall_number": "Z-0469-2013",
      "product_description": "Stryker Orthopaedics  FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS  REF 6543-1-600;NON-STERILE    Howmedica Osteonics Corp.  325 Corporate Drive  Mahwah, NJ  07430  USA  A Subsidiary of Stryker Corp.    Stryker France  ZAC Satolas Green Pusignan  Av de Satolas Green 69881 Meyzieu  Cedex France    The Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor, which allows for optimal bone coverage, compensating for differences between the Implant and bone canal axes.     Made in USA",
      "product_quantity": "7 units",
      "reason_for_recall": "Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise instead of clockwise; the Femoral Offset Bushing did not include rotational markings.",
      "recall_initiation_date": "20120727",
      "center_classification_date": "20121204",
      "termination_date": "20150930",
      "report_date": "20121212",
      "code_info": "Class I, 510(k) exempt    Catalog Number:  6543-1-600    Lot Number; NE1WR1"
    }
  ]
}