{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "123143",
      "product_res_number": "Z-0401-2014",
      "event_date_initiated": "2013-05-29",
      "event_date_posted": "2013-11-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-05-21",
      "res_event_number": "66723",
      "product_code": "JDP",
      "k_numbers": [
        "K110354"
      ],
      "product_description": "Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER\r\nSynthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.",
      "code_info": "part 04.124.406S, lot 3771678.",
      "firm_fei_number": "3005180112",
      "recalling_firm": "Synthes USA HQ, Inc.",
      "address_1": "1302 Wrights Ln E",
      "city": "West Chester",
      "state": "PA",
      "postal_code": "19380-3417",
      "additional_info_contact": "Customer Support\n610-719-5000",
      "reason_for_recall": "A plate was inadvertently released to a sales consultant that was restricted for sale.",
      "root_cause_description": "Employee error",
      "action": "Synthes sent a letter dated November 7, 2013, to the implanting surgeon to follow up on a complaint received.  The firm requested any additional information the surgeon might have about the use of the plate as well as a status on the patient following use.   For questions the surgeon was instructed to call 800-620-7025.\r\nFor questions regarding this recall call 610-719-5000.",
      "product_quantity": "1",
      "distribution_pattern": "US Distribution in Colorado.",
      "openfda": {
        "k_number": [
          "K110354",
          "K162124"
        ],
        "registration_number": [
          "3043620689",
          "8043792",
          "3015876273",
          "3009417901",
          "3013756169",
          "3015869493",
          "3008812560",
          "1526534",
          "3015440604",
          "3008868758",
          "3015399803",
          "3034676720",
          "3000270450",
          "3010363503"
        ],
        "fei_number": [
          "3002808269",
          "3015876273",
          "3013756169",
          "3009417901",
          "3015869493",
          "3043620689",
          "3008812560",
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          "3015440604",
          "3008868758",
          "3015399803",
          "3034676720",
          "3000270450",
          "3010363503"
        ],
        "device_name": "Condylar Plate Fixation Implant",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3030",
        "device_class": "2"
      }
    }
  ]
}