{
  "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-3201-2026",
      "product_description": "ACETABULAR CUP UHMWPE\t  \t61-3258  \t  ALL POLY CONSTRAINED INSERT 44MM\t  \t69-2244  \t  ALL POLY CONSTRAINED INSERT 46MM\t  \t69-2246  \t  ALL POLY CONSTRAINED INSERT 48MM\t  \t69-2248  \t  ALL POLY CONSTRAINED INSERT 50MM\t  \t69-2850  \t  ALL POLY CONSTRAINED INSERT 52MM\t  \t69-2852  \t  CONSTRAINED ACETABULAR INSERTS 22MM 50MM\t  \t2099-2250  \t  CONSTRAINED ACETABULAR INSERTS 22MM 52MM\t  \t2099-2252  \t  CONSTRAINED ACETABULAR INSERTS 22MM 56MM\t  \t2099-2256  \t  CONSTRAINED ACETABULAR INSERTS 28MM 61MM\t  \t2099-2861  \t  EIUS UNI TIB SMALL RM/LL 9MM\t  \t6636-0-419  \t  PCA CONST LINER 32MM NEUTRAL C - SHELL\t  \t6299-N-332  \t  SYS 12 CONST LINER 32ID 10 DEG P6 +4MM\t  \t6302-H-632  \t  TRIDENT 0 DEG CONSTRAINED INSERT 22D\t  \t690-00-22D  \t  TRIDENT 0 DEG CONSTRAINED INSERT 22E\t  \t690-00-22E  \t  TRIDENT 0 DEG CONSTRAINED INSERT 28F\t  \t690-00-28F  \t  TRIDENT 0 DEG CONSTRAINED INSERT 28G\t  \t690-00-28G  \t  TRIDENT 0 DEG CONSTRAINED INSERT 32I\t  \t690-00-32I    TRIDENT 0¿ POLY INSERT 28mm ID\t  \t620-00-28D  \t  TRIDENT CONSTR ACET INSERT\t  \t690-10-28K    TRIDENT CONSTRAINED INSERT\t  \t690-10-22E  \t690-10-22F  \t690-10-28G  \t690-10-28H  \t690-10-28I    \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": "61-3258    UDI-DI 07613327038538    Lots 191723   191867    69-2244    UDI-DI 07613327025446    Lots 990V1W   D56JV4   D74X5E   DX56K2   E67D6N   EP10WL   KP14HN   NN8NM2   P36TXM   P95L8X   RE4EK0   X82K0D    69-2246    UDI-DI 07613327025453    Lots 8X6EL1    69-2248    UDI-DI 07613327025460    Lots 9J3DPH   A41E7D   AD39A3   RP673W    69-2850    UDI-DI 07613327025477    Lots MLL1M3   MLLXT1   MLLY6H    69-2852    UDI-DI 07613327025484    Lots MLL0NM   MLLAHY    2099-2250    UDI-DI 07613327031430    Lots 1K5VVW   2367AK   3X0NJD   4W4MPL   LV80NE    2099-2252    UDI-DI 07613327031447    Lots NV561W   PM326V    2099-2256    UDI-DI 07613327031454    Lots 3H5RRK   AA7JK0    2099-2861    UDI-DI 07613327031591    Lot MLLVL6    6636-0-419    No UDI   Lot 13SFLA    6299-N-332    UDI-DI 07613327138870    Lot 19ECK    6302-H-632    UDI-DI 07613327138979    Lot 15NKT    690-00-22D    UDI-DI 07613327025538    Lots 123J5R   194RN0   274HMK   3M77NN   5J8P89   5L82T0   986HVM   A23P1X   E923WW   MLMEW8   MLMTVP   MLNPX0   VX6813    690-00-22E    UDI-DI 07613327025545    Lots 4100R9   5V78KA   711K4K   EY7HL9   KP576W   L620XW   MD8JH9   T61W43   XA0L27    690-00-28F    UDI-DI 07613327025552    Lots 284X4X   2K2DW1   E47WVY   MLL8JJ   MLLKAY   MLLP6K   MLLYT7   YE6959    690-00-28G    UDI-DI 07613327025583    Lots 6D8274   9N8EWW    690-00-32I    UDI-DI 07613327025590    Lots 3A2P68   4A40TV    620-00-28D    UDI-DI 07613327313581    Lot MET76R    690-10-28K    UDI-DI 07613327024449    Lots MHNRM4   MKRH1M   MLAAV7    690-10-22E    UDI-DI 07613327024289    Lots 29385D   906WEN   DJ7TP1   EK4TK5   LA22KA   WL248Y   XV01J8 690-10-22F    UDI-DI 07613327024357    Lots A6592H   L7140Y   P103P0   W745P8 690-10-28G    UDI-DI 07613327024326    Lot MLL4Y7 690-10-28H    UDI-DI 07613327024319    Lots MLKNT7   MLL1YN   MLLYXD 690-10-28I    UDI-DI 07613327024364    Lots MLL8L9   MLLXWY",
      "more_code_info": ""
    }
  ]
}