{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "195986",
      "product_res_number": "Z-1778-2022",
      "event_date_initiated": "2022-08-24",
      "event_date_posted": "2022-09-23",
      "recall_status": "Open, Classified",
      "res_event_number": "90836",
      "product_code": "KRQ",
      "k_numbers": [
        "K140898"
      ],
      "product_description": "Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.",
      "code_info": "Lot number B24694 (no UDI)",
      "firm_fei_number": "3003070421",
      "recalling_firm": "Howmedica Osteonics Corp.",
      "address_1": "325 Corporate Dr",
      "city": "Mahwah",
      "state": "NJ",
      "postal_code": "07430-2006",
      "additional_info_contact": "Keyla Colon\n201-831-5000",
      "reason_for_recall": "A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ.  However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not exchangeable for the MK3 tibial bearing. The surgeon needed to complete the surgery by re-assembling and re-inserting the extracted MK3 tibial bearing.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On August 24, 2022, the firm sent written notification (Product Field Action) to the single affected customer to document the event. The customer was asked to confirm their receipt of the notice.",
      "product_quantity": "1 unit",
      "distribution_pattern": "Distributed to one customer located in New York.",
      "openfda": {
        "registration_number": [
          "3009888740",
          "3011295718",
          "3010220595",
          "3021008900",
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          "1000306340",
          "1643264",
          "1000115656",
          "3036756245",
          "3001049282",
          "3033509898"
        ],
        "device_name": "Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3550",
        "device_class": "2"
      }
    }
  ]
}