Biomet 3i recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number: PPC484, Lot Numbers: 970773, 977566, 987984, 1003033, 1038519, 1038520, 1045556, 1046268, 1054540, 1059416, 1059512, 1065495, 1065497, 1071762, 1071763, 1073161, 1073163, 1108328, 1128077, 1139601, 1141281, 1141282, 1150838, 1153463, 1165800, 1167709, 1171489, 1172858, 1173629, 1179005, 1183068, 1184510. Model Number: PPC485, Lot Numbers: 1071764, 1071765, 1118826, 1143159, 1171487, 1178795, 1179690. Model Number PPC654, Lot Numbers: 977565, 987983, 1004138, 1009002, 1032456, 1033485, 1034852, 1035364, 1053562, 1053563, 1053564, 1053860, 1054512, 1065507, 1069998, 1069999, 1071165 , 1071167, 1088473, 1088475, 1104109, 1104110, 1121837, 1128074, 1128623, 1150839, 1153465, 1161360, 1165775, 1168905, 1168906, 1171488, 1173628, 1175898, 1177389, 1177390, 1181586, 1181587, 1184511, 1185509, 1185511. Model Number PPC655, Lot Numbers: 1032473, 1057790, 1086562, 1088470, 1166995, 1176293.

Product

BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to…

Recalling firm

Biomet 3i, LLC

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.

Recall date

January 13, 2016

Classification

Class II

Status

Terminated

Agency

FDA (device)