Biomet 3i, LLC: 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.

Recall number

Z-0592-2016

Recalling firm

Biomet 3i, LLC

Product

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.

Status

Terminated

Initiated

2015-09-21

Posted

2016-01-06

Terminated

2016-10-12

Reason

Inadequate biocompatibility testing.

Root cause

Process control

Action

The firm, Biomet 3i, sent an "URGENT DEVICE RECALL NOTICE" letter dated September 16, 2015 to both Domestic and Foreign Customers via traceable courier. The letter described the product, problem and actions to be taken. The customers were instructed to review the notice and check your inventory for the affected units; immediately quarantine and remove all affected products from service; if you have product to return, call Biomet 3i Complaints Department at 1-800-443-8166 or 1-561-776-6700 to obtain a CMP# and return affected product to Biomet 3i Returns, 4555 Riverside Dr., Palm Beach Gardens, FL 34410; complete and return the attached Business Reply Form via fax to: +1-561-514-6316 or email to: postmarket@biomet.com, and maintain a copy of the notice for your records. For assistance or any other questions that you may have, please contact Biomet 3i Complaints Department at 1-800-443-8166 or 1-561-776-6700. The Complaints Department is available 8:00am to 6:00pm (Eastern), Monday through Friday.

Quantity

30,111 devices.

Distribution

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.

Lot, serial or model codes

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.

510(k) numbers

["K934126"]

PMA numbers

not on file

Product code

DZE

Firm FEI

1038806

Firm city

Palm Beach Gardens

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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