{
  "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-3206-2026",
      "product_description": "SCORPIO C-DOME PATELLA\t  \t73-2710  \t73-2910  \t  SCORPIO U-DOME PATELLA\t  \t73-3110  \t73-3508  \t73-3708  \t73-3710  \t73-3910      \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": "73-2710    UDI-DI 07613327033847    Lot NPPV 73-2910    UDI-DI 07613327033854    Lot 14AGFD    73-3110    UDI-DI 07613327033861    Lots 1L45   4JM5   7EL5   AME3   MK74   NTV7   PYHM   RE7J   VEWJ 73-3508    UDI-DI 07613327033885    Lots HMM5   NLRE 73-3708    UDI-DI 07613327033892    Lots 3467   3D8D   PMRHX1   T6YJ   T9ME   VWDA   YAM7 73-3710    UDI-DI 07613327033908    Lots 3W25   DLYP 73-3910    UDI-DI 07613327033915    Lots 14NEYA   1XED   9Y3T   D1M9   D2YP   EX8T   KRT3   KRT3X1   T325   V8X8   X6YE",
      "more_code_info": ""
    }
  ]
}