{
  "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": 12
    }
  },
  "results": [
    {
      "cfres_id": "221858",
      "product_res_number": "Z-3195-2026",
      "event_date_initiated": "2026-07-30",
      "event_date_posted": "2026-09-16",
      "recall_status": "Open, Classified",
      "res_event_number": "99558",
      "product_code": "JDC",
      "k_numbers": [
        "K980502"
      ],
      "product_description": "AXLE PIN ASSY LARGE ELBOW COBALT CHROME\r\nCatalog No. C-M112-2-500\t\r\n\t\r\nOrthopaedic implant components manufactured from UHMWPE (polyethylene)",
      "code_info": "No UDI-DI\nLot P22E159",
      "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": "Evelyn Ryan\n201-831-5000",
      "reason_for_recall": "Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.",
      "root_cause_description": "Process change control",
      "action": "Firm began notifying customers on July 30, 2026, via FedEx 2-day air.\n\nCustomers were instructed to quarantine and discontinue use of the affected product. Affected product should be returned to the firm.",
      "product_quantity": "12,156 US",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.",
      "openfda": {
        "k_number": [
          "K992656",
          "K153398",
          "K982398",
          "K980502",
          "K001989",
          "K013042",
          "K181362",
          "K904021",
          "K955916",
          "K053189",
          "K861680",
          "K003253",
          "K000683",
          "K181307",
          "K901581",
          "K150501",
          "K033280",
          "K060696",
          "K042664",
          "K983036",
          "K090473",
          "K000003",
          "K980428",
          "K883665",
          "K872084",
          "K040389",
          "K123862",
          "K973357",
          "K051975"
        ],
        "registration_number": [
          "3004976965",
          "3009888740",
          "3026771806",
          "3013791180",
          "2245304",
          "3011461101",
          "1424263",
          "3005061536",
          "3009887475",
          "1835251",
          "1822565",
          "3007740680",
          "3010057495",
          "3004153896",
          "1828288",
          "3011015572",
          "1721676",
          "3000931034",
          "1834331",
          "1644408",
          "3010041511",
          "2249615",
          "2249697",
          "3015207155",
          "3003387384",
          "2242737",
          "3035366890",
          "9614841",
          "1061124",
          "3011274144",
          "3003639920",
          "9681465",
          "1828464",
          "3009888344",
          "3006017180",
          "3002807295",
          "1721686",
          "3007993775",
          "1818910",
          "3002806470",
          "1529009",
          "3008021110",
          "1220477",
          "3017397663",
          "3014302784",
          "1226544",
          "3004371426",
          "1649390",
          "1645151",
          "3015542154",
          "3025603301",
          "1526350",
          "3010041993",
          "3014315560",
          "3008337808",
          "2528981",
          "3013176080",
          "1825034",
          "3010178296",
          "9680794",
          "1221934",
          "3008395353",
          "1423662",
          "1526534",
          "1834379",
          "3002806603",
          "3015859709",
          "3004983210",
          "1450662",
          "3009518015",
          "3036756245",
          "3011683674",
          "3033509898"
        ],
        "fei_number": [
          "3003015552",
          "1000116912",
          "3004976965",
          "3009888740",
          "3026771806",
          "3013791180",
          "1000149660",
          "2245304",
          "1000306303",
          "3011683674",
          "3011461101",
          "3005061536",
          "3009887475",
          "3007740680",
          "3010057495",
          "3000205591",
          "3004153896",
          "1828288",
          "1000118610",
          "3011015572",
          "3001049282",
          "1721676",
          "3000931034",
          "3003386935",
          "3003070421",
          "3010041511",
          "3015207155",
          "3003387384",
          "3002808402",
          "3035366890",
          "3011274144",
          "3003639920",
          "1828464",
          "3009888344",
          "3006017180",
          "3002807295",
          "1721686",
          "1000512168",
          "3007993775",
          "3002806470",
          "1818910",
          "3003110073",
          "3008021110",
          "1220477",
          "3017397663",
          "3014302784",
          "3001548076",
          "3015542154",
          "3025603301",
          "1526350",
          "3010041993",
          "3014315560",
          "3008337808",
          "1000306340",
          "3013176080",
          "2528981",
          "1825034",
          "3003128516",
          "1221934",
          "3008395353",
          "1526534",
          "3003737899",
          "3002806603",
          "1450662",
          "3015859709",
          "3004983210",
          "3009518015",
          "3036756245",
          "3002807113",
          "3000718467",
          "3000215273",
          "3033509898",
          "1000220733"
        ],
        "device_name": "Prosthesis, Elbow, Constrained, Cemented",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3150",
        "device_class": "2"
      }
    }
  ]
}