{
  "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": "2026-09-23",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99558",
      "recalling_firm": "Howmedica Osteonics Corp.",
      "address_1": "325 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "07430-2006",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.",
      "recall_number": "Z-3202-2026",
      "product_description": "BEARING AND AXLE BUSHING ASSY STD ELBOW\t  \tC-M113-1-301  \t  KRH REV TIB INS 16mm THK .640 DIA STEM\t  \tC-M113-5-600  \t  SELF-PRESSURIZING GLENOID SIZE 9\t  \tC-M063-5-800  \t  Orthopaedic implant components manufactured from UHMWPE (polyethylene)",
      "product_quantity": "12,156 US",
      "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.",
      "recall_initiation_date": "20260730",
      "center_classification_date": "20260916",
      "report_date": "20260923",
      "code_info": "C-M113-1-301    UDI-DI 07613327590074    Lot MH621A    C-M113-5-600    No UDI   Lot 194593    C-M063-5-800    No UDI   Lot RX06358A",
      "more_code_info": ""
    }
  ]
}