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.
Enforcement
- Recall Number
- Z-0594-2016
- Event ID
- 72446
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Biomet 3i, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- January 13, 2016
- Initiation Date
- September 21, 2015
- Classification Date
- January 5, 2016
- Termination Date
- October 12, 2016
- Address
- 4555 Riverside Dr, N/A, Palm Beach Gardens, FL, 33410-4200, United States
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.
Inadequate biocompatibility testing.
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.
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.
30,111 devices.