Reported Jan 13, 2016 · Terminated
BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H…
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 IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H 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
8 of 8 products
Products covered by this recall Model / number Product as published PIC484Lot Numbers: 942680, 950198, 950706, 957203, 963249, 973436, 977567, 993384, 1004520, 1015298, 1024240, 1034518, 1048991, 1057119, 1095480, 1105770, 1131300, 1133485, 1158650, 1165796, 1169295, 1172741, 1175519, 1178568, 1181589, 1184490 PIC484HLot Numbers: 952664, 1023220, 1034517, 1057121, 1084058, 1085156, 1086404, 1115750, 1169297, 1174217, 1182906, 1187568 PIC485Lot Numbers: 1137568, 1137603, 1176653, 1184855 PIC485HLot Numbers: 1113005, 1170171, 1181580 PIC654Lot Numbers: 934480, 950196, 954781, 957204, 961452, 977568, 988996, 1016258, 1024427, 1034516, 048990, 1060550, 1073328, 1073329, 1092256, 1105771, 1115811, 1115812, 1115813, 1115815, 1115816, 1116774 PIC654HLot Numbers: 970700, 988995, 989022, 1015301, 1043973, 1069114, 1073325, 1073327, 1074848, 1147383, 1166591, 1174216, 1184508, 1184509 PIC655Lot Numbers: 1040760, 1044047, 1048195, 1115778 PIC655HLot Numbers: 1031581, 1079916, 973403-S1. - 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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