{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "219759",
      "product_res_number": "Z-2308-2026",
      "event_date_initiated": "2026-04-03",
      "event_date_posted": "2026-06-04",
      "recall_status": "Open, Classified",
      "res_event_number": "98773",
      "product_code": "ETB",
      "k_numbers": [
        "K060518"
      ],
      "product_description": "TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L  \nModel/Catalog Number: 409-375\n  \nProduct Description: Stapes Prosthesis",
      "code_info": "Model/Catalog Number: 409-375\nUDI code: (01)00844505000772(10)122927(17)310301\nLot Number: 122927",
      "firm_fei_number": "1000022662",
      "recalling_firm": "Grace Medical, Inc.",
      "address_1": "8500 Wolf Lake Dr Ste 110 8500 Wolf Lake Dr",
      "address_2": "Ste 110",
      "city": "Bartlett",
      "state": "TN",
      "postal_code": "38133-4104",
      "additional_info_contact": "901-380-7000",
      "reason_for_recall": "Due to incorrect functional length on device labeling.",
      "root_cause_description": "Process control",
      "action": "On 04/03/2026, the firm emailed a \"RECALL NOTICE\" to it single customer informing them that the firm  determined the pistons were manufactured with an incorrect functional length. Devices are labeled as 3.75 mm but have an actual functional length of 4.00 mm.\n\nThe customer was instructed to:\n\" Immediately discontinue use and quarantine affected product\n\" Return affected product using the provided RMA\n\" If any devices have been used, provide the date(s) of surgery on the response form\n\" Complete and return the enclosed Recall Response Form\n\nFor questions - contact Grace Medical at 901-386-0990 or Thomas.fearnley@gracemedical.com.",
      "product_quantity": "7",
      "distribution_pattern": "U.S Nationwide distribution in the state of MD.",
      "openfda": {
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          "K112616",
          "K883727",
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          "K021479",
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        ],
        "registration_number": [
          "9612501",
          "3003790304",
          "1057421",
          "3008812251",
          "8044131",
          "8010617",
          "1048735",
          "9610617",
          "3001239363",
          "9616949",
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          "2020550",
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          "1928237",
          "1037007",
          "3008132398",
          "3011050570",
          "1052728",
          "3010202439"
        ],
        "fei_number": [
          "3002808293",
          "3003790304",
          "3003495548",
          "1048735",
          "3001239363",
          "1000022662",
          "3018094310",
          "3006849754",
          "3002807091",
          "3010707607",
          "3003051996",
          "2020550",
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          "3000249315",
          "3004545399",
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          "3014342096",
          "6062",
          "3007475226",
          "1045254",
          "1000113735",
          "3017636737",
          "1928237",
          "1037007",
          "3002808268",
          "3011050570"
        ],
        "device_name": "Prosthesis, Partial Ossicular Replacement",
        "medical_specialty_description": "Ear, Nose, Throat",
        "regulation_number": "874.3450",
        "device_class": "2"
      }
    }
  ]
}