{
  "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-3200-2026",
      "product_description": "DURACON XL ANGLED TIB INS 11/14MM\t  \tC-M064-1-300  \t  SELF-PRESSURIZING GLENOID SIZE 8\t  \tC-M062-6-800  \tC-M062-7-500\t  \tC-M063-2-600  \t  SELF-PRESSURIZING GLENOID SIZE 9\t  \tC-M063-5-000  \t  SHOULDER - GLENOID #11\t  \t5361-6111    SHOULDER - GLENOID #5\t  \t5361-6105    SHOULDER - GLENOID #7\t  \t5361-6107  \t  SHOULDER - GLENOID #9\t  \t5361-6109    SHOULDER - KEELED GLENOID #11\t  \t5361-6211    SHOULDER - KEELED GLENOID #5\t  \t5361-6205    SHOULDER - KEELED GLENOID #7\t  \t5361-6207  \t  SHOULDER - KEELED GLENOID #9\t  \t5361-6209      \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-M064-1-300    No UDI   Lot RX06413A    C-M062-6-800    No UDI    Lot RX06268A  C-M062-7-500    No UDI   Lot RX06275A C-M063-2-600    No UDI    Lot RX06326A    C-M063-5-000    No UDI   Lots RX06350A   RX06350AA    5361-6111    UDI-DI 07613327138191    Lots AFZT00U   AFZT00Z   P2N04B   P3K57   P3K57B   P3K57F   PYE43B   PZA70F   PZA70U    5361-6105    UDI-DI 07613327138214    Lots AF2S09U   AF2S09Z   P1H41   P4T02   P4T02X1   P4T02X2   P4T02X3   P4T02X4   P4T02X5   P4T02X6    5361-6107    UDI-DI 07613327138207    Lots AF3E00   AF3E00B   AF3E00F   AF3E00G   AF3E00Q   AF3E00S   P4A238   P4A238X1   P4A238X2   P4A238X3   P4A238X4   P4A238X5   P4A238X6   P4A238X7   P4A238X8   P4L09   P4L09X1   P4L09X10   P4L09X2   P4L09X3   P4L09X4   P4L09X5   P4L09X6   P4L09X7   P4L09X8   P4L09X9   P4N06   P4N06X1   P4N06X2   P4N06X3   P4N06X4   P4N06X5   P4N06X6   P4N06X7   P4T03   P4T03X1   P4T03X2   P4T03X3   P4T03X4   P4T03X5   P4T03X6   P4T03X7   P4T03X8   P4V01   P4V01X1   P4V01X2   P4V01X3   P4V01X4   P4V01X5   P4V01X6   P4V01X7   P4V01X8    5361-6109    UDI-DI 07613327138153    Lots AF3E02I   AF3E02S   AF3E02Z   P1H39Q    5361-6211    UDI-DI 07613327138283    Lots AFZS09F   AFZS09G   AFZS09S   P2N08   PYC30X1   PYW24X1   PZKDHX1    5361-6205    UDI-DI 07613327138177    Lots 1NMMPE   1NNMPE   P3K58   P3K58B   P3K58F    5361-6207    UDI-DI 07613327138269    Lots AF2S10B   AF2S10F   AF2S10G   P4A241   P4A241X1   P4A241X2   P4A241X3   P4V03   P4V03X1   P4V03X2   P4V03X3   P4V03X4   P4V03X5   PZKDFX1    5361-6209    UDI-DI 07613327138238    Lots AF2K03Z   AFZS10S   AFZS10U",
      "more_code_info": ""
    }
  ]
}