{
  "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": "92220",
      "product_res_number": "Z-0444-2011",
      "event_date_initiated": "2010-05-18",
      "event_date_posted": "2010-11-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-05-18",
      "res_event_number": "55889",
      "product_code": "OFY",
      "product_description": "Zimmer Dental, Drill stop kit, REF DSKIT, for use with dental implants.",
      "code_info": "61482528, 61484443, 61495269 and 61479592.",
      "firm_fei_number": "1000220733",
      "recalling_firm": "Zimmer Inc.",
      "address_1": "345 E Main St",
      "city": "Warsaw",
      "state": "IN",
      "postal_code": "46580-2746",
      "additional_info_contact": "574-267-6131",
      "reason_for_recall": "The instructions for use contain pre-vacuum sterilization  instructions that may lead to compromised sterility at the lid-kit interface location.",
      "root_cause_description": "Labeling design",
      "action": "Zimmer sent out \"Urgent Device Correction\" letters dated 5/18/2010. The consignees were provided with new instructions for use.  The letter informed users that the current pre-vacuum cycle of 3 to 18 minutes is not enough time to assure sterility between the lid-kit interface and could lead to cross contamination of multiple patients.  The users were informed that a pre-vacuum time of 30 minutes was required to assure sterility.",
      "product_quantity": "158",
      "distribution_pattern": "Distribution Nationwide, to France, and Spain.",
      "openfda": {
        "device_name": "Dental Implant Surgical Tray",
        "medical_specialty_description": "Dental",
        "regulation_number": "872.3980",
        "device_class": "1",
        "registration_number": [
          "3010948854",
          "3004417597",
          "3007329020",
          "3005587147",
          "8040278",
          "1643817",
          "3009888344",
          "8010516",
          "1221053",
          "3013463240",
          "3004111573",
          "1423537",
          "3025338240",
          "3011936113",
          "3004443656",
          "3008346537",
          "3010730876",
          "9616088",
          "3008534770",
          "1061124",
          "3009727738",
          "3007518363",
          "3013022399"
        ],
        "fei_number": [
          "3004169071",
          "3002902735",
          "3010948854",
          "3001236905",
          "3004417597",
          "3007329020",
          "3005587147",
          "1643817",
          "3009888344",
          "1221053",
          "3013463240",
          "3004111573",
          "3025338240",
          "3011936113",
          "3004443656",
          "3008346537",
          "3010730876",
          "1000512168",
          "3008534770",
          "3004216008",
          "3009727738",
          "3007518363",
          "3013022399"
        ]
      }
    }
  ]
}