{
  "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-3197-2026",
      "product_description": "ALL POLY CONSTRAINED INSERT 54MM\t  \t69-2854  \t  NRG KNEE CR\t  \t82-2-0512\t  \t82-2-0518  \t82-2-0912    NRG KNEE P/S\t  \t82-3-0318  \t  SCORPIO + MOBILE BEARING PCS\t  \t78-5-0910    SCORPIO C-DOME PATELLA\t  \t73-2710  \t\t  SCORPIO INSET PATELLA\t  \t73-2610  \t  \t\t  SCORPIO M-DOME PATELLA\t  \t73-0110  \t73-0710  \t73-0910  \t  SCORPIO RECESSED PATELLA 26MM\t  \t3044-0026    SCORPIO TS TIB INS\t  \t72-4-9114  \t\t  SCORPIO TS TIBIAL INSERT\t  \t72-4-0324  \t\t  SCORPIOFLEX TOTAL KNEE CR\t  \t72-16-0512  \t72-16-0518  \t72-16-0912  \t72-16-1112  \t  SERIES II TIBIAL BEAR INSERT NO 11 15MM\t  \t3052-1115  \t  UHR BIPOLAR 26X52mm\t  \tUH1-52-26  \t  UHR BIPOLAR 26X58mm\t  \tUH1-58-26  \t  UHR BIPOLAR 28X48mm\t  \tUH1-48-28    UHR BIPOLAR 28X52mm\t  \tUH1-52-28\t  \t  UHR BIPOLAR 28X55mm\t  \tUH1-55-28\t  \t  UHR BIPOLAR 32X49MM\t  \tUH1-49-32\t  \t  UHR BIPOLAR 32X51MM\t  \tUH1-51-32\t  \t  UHR BIPOLAR 32X52MM\t  \tUH1-52-32\t\t  \t  UHR BIPOLAR 32X54MM\t  \tUH1-54-32  \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": "69-2854    UDI-DI 07613327025491    Lots MLKY8A   MLL8E1    82-2-0512    UDI-DI 04546540400611    Lot 23325151 82-2-0518    UDI-DI 04546540400635    Lot 23640051 82-2-0912    UDI-DI 04546540400758    Lot 26862851    82-3-0318    UDI-DI 04546540364319    Lot 28208551    78-5-0910    UDI-DI 07613327366006    Lots 30582401   30582601    73-2710    UDI-DI 07613327033847    Lot 14HDSA    73-2610    UDI-DI 07613327014082    Lots 193307A   193307E    73-0110    UDI-DI 07613327050288    Lot HHPW 73-0710    UDI-DI 07613327050295    Lots 8P83   DL4V 73-0910    UDI-DI 07613327050332    Lot 14NACD    3044-0026    UDI-DI 07613327033779    Lots 14SCVA   14SCVD   14SCVF    72-4-9114    UDI-DI 07613327034875    Lot 8H39KP    72-4-0324    UDI-DI 07613327034356    Lot 23505751    72-16-0512    UDI-DI 07613154020515    Lots 17376651   19093651   23125951   27835951 72-16-0518    UDI-DI 07613154020539    Lot 25621551 72-16-0912    UDI-DI 07613154020652    Lot 17879451 72-16-1112    UDI-DI 07613154020737    Lot 22764851    3052-1115    UDI-DI 07613327034240    Lot MJ7YY6    UH1-52-26    UDI-DI 07613327017168    Lot 5J8PM2    UH1-58-26    UDI-DI 07613327017359    Lots 1R8TNH   414A2L   4W1HD7   AV0J7J   E226XA   E50DAW   M31665   WK1WP2   X90ML6    UH1-48-28    UDI-DI 07613327017014    Lots N046DW   N06WWP   N20WDM   N75AY1   P419XW   RP3D0X   TD218R   V15WA1   VH06PA   VN3P18   VR853H   WM8KJT   XE2ND8   YH0N93    UH1-52-28    UDI-DI 07613327017182    Lot V02MME    UH1-55-28    UDI-DI 07613327017281    Lot R30MME    UH1-49-32    UDI-DI 07613327017069    Lot 324H9H    UH1-51-32    UDI-DI 07613327017120    Lot 9J6N9E    UH1-52-32    UDI-DI 07613327017212    Lots 5D4NMJ   9T612E    UH1-54-32    UDI-DI 07613327017267    Lot MNNAAL",
      "more_code_info": ""
    }
  ]
}