{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "38869",
      "product_res_number": "Z-0241-06",
      "event_date_initiated": "2004-11-22",
      "event_date_posted": "2005-12-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-10-03",
      "res_event_number": "31985",
      "product_code": "NDH",
      "k_numbers": [
        "K034002"
      ],
      "product_description": "Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right.  And 125 degree Nail.",
      "code_info": "Catalog 3220-0320S Lot K949408  3225-0360S, lot code K949396",
      "firm_fei_number": "3003070421",
      "recalling_firm": "Stryker Howmedica Osteonics Corp.",
      "address_1": "325 Corporate Dr",
      "city": "Mahwah",
      "state": "NJ",
      "postal_code": "07430-2002",
      "additional_info_contact": "Dominick Cristofolo\n201-831-5247",
      "reason_for_recall": "The Gamma Nail may have been manufactured with an incorrect lag screw hole angulation.\nCatalog number 3225-0360S, lot code K949396 was manufactured with a lag screw hole angulation of 120 degrees instead of 125 degrees.   Catalog number 3220-0320S, lot code K949408 was manufactured with a lag screw hole angulation of 125 degrees instead of 120 degrees.",
      "root_cause_description": "Other",
      "action": "Notification letters and Product Accountability forms were sent via FedEx on 11/22/2004 with return receipt.",
      "product_quantity": "19",
      "distribution_pattern": "The product was sent to Stryker Orthopaedics branches and agents throughout the US.  There was one hospital that was a direct account.",
      "openfda": {
        "registration_number": [
          "3015542154",
          "3011683674",
          "1825034",
          "3015207155",
          "3035366890",
          "3006801265",
          "3013176080"
        ],
        "fei_number": [
          "3015542154",
          "3011683674",
          "1825034",
          "3015207155",
          "3035366890",
          "3006801265",
          "3013176080"
        ],
        "device_name": "Nail, Fixation, Bone, Metallic",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3030",
        "device_class": "2"
      }
    }
  ]
}