Reported Jan 13, 2016 · Terminated
BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440,…
Biomet 3i, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomet 3i, LLC · 4555 Riverside Dr · Palm Beach Gardens, FL · 33410-4200
Is this the product you have?
- BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 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.
- Lot codes and dates
24 of 24 products
Products covered by this recall Model / number Product as published PAK4140Lot Numbers: 977597, 981669, 984020, 987879, 989549, 995908, 1001595, 1004140, 1008710, 1010960, 1014334, 1015290, 1040122, 1040123, 1041414, 1045559, 1051854, 1052717, 1057786, 1062286, 1062287, 1062316, 1062317, 1065506, 1069146, 1069147, 1069996, 1075432, 1077541, 1077695, 1079484, 1087552, 1092512, 1095127, 1101673, 1108857, 1116020, 1124781, 1126602, 1133466, 1138040, 1142164, 1142165, 1142166,1142167, 1146388, 1146389, 1146390, 1154210, 1155762, 1161343, 1165414, 1166599, 1169299, 1170515, 1171394,1172306,1172307,1173594,1177247, 1177864, 1180531, 1180696, 1182190, 1182794, 1184132, 1184574, 1184575 PAK4155Lot Numbers: 1093011, 1109345, 1124776, 1130228, 1147152, 1165412, 1173301, 1179689, 1179946, 1181748, 1182412, 1183051, 1183632 PAK4240Lot Numbers: 976863, 984016, 989553, 1002872, 1008694, 1014133, 1040125, 1040126, 1053095, 1053272, 1054998, 1057787, 1059216, 1062288, 1062289, 1062315, 1063247, 1065954, 1069997, 1075433, 1077542, 1078854, 1100721, 108854, 1115057, 1118381, 1130245, 1133478,1142170, 1142171, 1145306, 1145307, 147153, 1154213, 1161339, 1165350, 1166597, 1166982, 171069, 1171551, 1172742, 1173592, 1174352, 1175517, 1177865, 1179604, 1183052, 1184133, 1184577, 1184578 PAK4255Lot Numbers: 1101674, 1101932, 1145936, 1165798, 1172302, 1182694 PAK4340Lot Numbers: 984895, 996687, 1040764, 1054537, 1062290, 1063244, 1063585, 1071105, 1076277, 1139560, 145302,1150519, 1166596,1174356, 1184854 PAK4355Lot Numbers: 1076102, 1095125, 1124758, 1178454 PAK4440Lot Numbers: 990071, 1040763, 1062307, 1062314, 1165408, 1173300, 1175589 PAK4455Lot Numbers: 1143174, 1166992 PAK5140Lot Numbers: 987881, 992597, 993051, 1008713, 1016816, 1027348, 1030633, 1040152, 1053291, 1053292, 1055001, 1057776, 1059419, 1060681, 1060683, 1064187, 1068777, 1074334, 1075711, 1077697, 1090897, 1095824, 1109271, 1111471, 1119708, 1130992, 1133468, 1137566, 1147648, 1161335, 1165351, 1166598, 1170516, 1173302, 1175590, 1177233, 1178497, 1180268, 1182894, 1184581, 1186589 PAK5155Lot Numbers: 1041413, 1057788, 1063243, 1070055, 1071759, 1104117, 1148540, 1173305, 1185657 PAK5240Lot Numbers: 980399, 985506, 996408, 1007895, 1014099, 1016185, 1028721, 1040149, 1041536, 1059511, 1060043, 1060680, 1062313, 1064628, 1069149, 1074333, 1075709, 1077543, 1088474, 1088476, 1109337, 1113209, 1134520, 1148634, 1161340, 1166594, 1170178, 1172113, 1173461, 1174931, 1180198, 1180199, 1182651, 1183054, 1184580 PAK5255Lot Numbers: 1042331, 1057791, 1063087, 1071336, 1090926, 1099823, 1131855, 1170697, 1185655 PAK5340Lot Numbers: 989548, 1007893, 1030631, 1048667, 1054937, 1063528, 1068338, 1075434, 1116022, 1166993 PAK5355Lot Numbers: 1100717, 1170177, 1176295, 1184856 PAK5440Lot Numbers: 1007892, 1062309, 1069150, 1115058,1165410, 1177485 PAK5455Lot Numbers: 1090053, 1174219 PAK6140Lot Numbers: 984892, 1007891, 1040155, 1057789, 1063085, 1090930, 1109781, 1154439, 1174355 PAK6155Lot Numbers: 1060679, 1096852, 1148501, 1165347 PAK6240Lot Numbers: 996407, 1040156, 1051074, 1057792, 1070221, 1076288, 1138038, 1176971 PAK6255Lot Numbers: 1063084, 1178839 - Amount recalled
- 30,111 devices.
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Inadequate biocompatibility testing.
This product could cause temporary or reversible health problems — stop using it.
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