{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Palm Beach Gardens",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "72446",
      "recalling_firm": "Biomet 3i, LLC",
      "address_1": "4555 Riverside Dr",
      "address_2": "N/A",
      "postal_code": "33410-4200",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and countries of: Canada, Argentina, Austria, Australia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Ireland, Israel, India, Korea, Kuwait, Lithuania, Mexico, Netherlands, Portugal, Saudi Arabia, Sweden, Singapore, Taiwan, Venezuela, and South Africa.",
      "recall_number": "Z-0594-2016",
      "product_description": "BIOMET 3i, PROVIDE IMPRESSION COPING KITS,  Catalog # PRK484, PRK485, PRK654, and PRK655    BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.",
      "product_quantity": "30,111 devices.",
      "reason_for_recall": "Inadequate biocompatibility testing.",
      "recall_initiation_date": "20150921",
      "center_classification_date": "20160105",
      "termination_date": "20161012",
      "report_date": "20160113",
      "code_info": "Model Number:  PRK484, Lot Numbers:  929282 , 948311, 949496, 949497, 949668, 950083, 952452, 954303, 957220, 957368, 960733, 963052, 963054, 971802, 975153, 977973, 979767, 984897, 987880, 989210, 992599, 996689, 1001596, 1004143, 1008573, 1012089, 1013629, 1015576, 1023526, 1030628, 1033053, 1036120, 1041405,1044169,1046263, 1055914, 1055916, 1062672,1062819,1063241, 1064625,1065949, 1069639, 1071532, 1073172, 1075436, 1079918, 1083264, 1086406, 1089300, 1095122, 1098706, 1100723,1104907,1108327,1113200, 1119709, 1124780, 1128073, 1130255, 1131856, 1145310, 1147645, 1153461, 1161337, 1162496, 1166592, 1166593, 1166987, 1170183, 1171068, 1172744, 174130, 1176170, 1176650, 1177487, 1179602, 1181083, 1182414, 1183058, 1184585, 184586,  1185984;     Model Number:  PRK485, Lot Numbers:   1117971, 1127401, 1148502,  1165797, 1170173, 1174218, 1181185, 1184583;    Model Number:  PRK654, Lot Numbers:   929284, 948045, 952097, 952481, 952482, 957221, 957222, 957369, 961075, 961076, 966055, 971292, 976372, 978223, 979359, 984019, 987878, 991534, 996579, 1001594, 1004519, 1008716, 1013056, 1013628, 1016826, 1029923, 1031579, 1033052, 1036122, 1041538, 1051466, 1051616, 1053274, 1063078, 1063080, 1063531, 1064519, 1065947, 1069154, 1070308, 1070323, 1071531,  1072663, 1075435, 1077545, 1079499, 1080408, 1082647, 1087546, 1088471, 1091356, 1095135, 1101665,1105924,1108322, 1111753, 1122177, 1124967, 1127403, 1143157, 1146493, 1149132 , 1161341, 1165349, 1165799, 1170181, 1170182, 1170956, 1172743, 1176568, 1178724, 1179004, 1179951, 1181463, 1184279, 1184572, 1184573, 1186937;    Model Number:  PRK655, Lot Numbers:  977274,  992602, 1005231, 1027142, 1031582, 1036123, 1049035, 1049035, 1055858, 1055858, 1059763, 1059763, 1060690, 1060690, 1063239, 1063239, 1071325, 1071325, 1086079, 1104105, 1104105,1128070, 1151635,  166984, 1166984, 1181738, 1181738."
    }
  ]
}