FDA Device recall Z-0592-2016

BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155,…

FDA Device
Class II
terminated
Published 2016-01-13

On 2016-01-13 the FDA classified a Class II recall of BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155,… by Biomet 3i, citing inadequate biocompatibility testing.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0592-2016
Classification	Class II
Status	terminated
Initiated	2015-09-21
Published	2016-01-13
Last updated	2026-09-13 11:54 UTC
Company	Biomet 3i
Distribution	US

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.

Reason

Inadequate biocompatibility testing.

Identifiers

code_info	Model Number: PAK4140, Lot Numbers: 977597, 981669, 984020, 987879, 989549, 995908, 1001595, 1004140, 1008710, 101096… 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, 1065

code_info

Model Number: PAK4140, Lot Numbers: 977597, 981669, 984020, 987879, 989549, 995908, 1001595, 1004140, 1008710, 101096…

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, 1065

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0592-2016%22

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