Biomet 3i, LLC: Medical Device Recall in 2016 - (Recall #: Z-0592-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 21, 2015

Date Posted: January 13, 2016

Recall Number: Z-0592-2016

Event ID: 72446

Reason for Recall:

Inadequate biocompatibility testing.

Status: Terminated

Product Quantity: 30,111 devices.

Code Information:

Model Number: PAK4140, Lot 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; Model Number: PAK4155, Lot Numbers: 1093011, 1109345, 1124776, 1130228, 1147152, 1165412, 1173301, 1179689, 1179946, 1181748, 1182412, 1183051, 1183632; Model Number: PAK4240, Lot 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; Model Number: PAK4255, Lot Numbers: 1101674, 1101932, 1145936, 1165798, 1172302, 1182694; Model Number: PAK4340, Lot Numbers: 984895, 996687, 1040764, 1054537, 1062290, 1063244, 1063585, 1071105, 1076277, 1139560, 145302,1150519, 1166596,1174356, 1184854; Model Number: PAK4355, Lot Numbers: 1076102, 1095125, 1124758, 1178454; Model Number: PAK4440, Lot Numbers: 990071, 1040763, 1062307, 1062314, 1165408, 1173300, 1175589; Model Number: PAK4455, Lot Numbers: 1143174, 1166992; Model Number: PAK5140, Lot 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; Model Number: PAK5155, Lot Numbers: 1041413, 1057788, 1063243, 1070055, 1071759, 1104117, 1148540, 1173305, 1185657; Model Number: PAK5240, Lot 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; Model Number: PAK5255, Lot Numbers: 1042331, 1057791, 1063087, 1071336, 1090926, 1099823, 1131855, 1170697, 1185655; Model Number: PAK5340, Lot Numbers: 989548, 1007893, 1030631, 1048667, 1054937, 1063528, 1068338, 1075434, 1116022, 1166993; Model Number: PAK5355, Lot Numbers: 1100717, 1170177, 1176295, 1184856; Model Number: PAK5440, Lot Numbers: 1007892, 1062309, 1069150, 1115058,1165410, 1177485; Model Number: PAK5455, Lot Numbers: 1090053, 1174219; Model Number: PAK6140, Lot Numbers: 984892, 1007891, 1040155, 1057789, 1063085, 1090930, 1109781, 1154439, 1174355; Model Number: PAK6155, Lot Numbers: 1060679, 1096852, 1148501, 1165347; Model Number: PAK6240, Lot Numbers: 996407, 1040156, 1051074, 1057792, 1070221, 1076288, 1138038, 1176971; Model Number: PAK6255, Lot Numbers: 1063084, 1178839; Model Number: PAK6340, Lot Numbers: 984894, 1057794, 1090929, 1116021; Model Number: PAK6355, Lot Number: 1062806; Model Number: PAK6440, Lot Number: 993055; Model Number: PAK6455, Lot Number: 1116019.

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.

Voluntary or Mandated:

Voluntary: Firm initiated