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U.S. Department of Health and Human Services

Class 2 Device Recall PROVIDE IMPRESSION COPINGS

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  Class 2 Device Recall PROVIDE IMPRESSION COPINGS see related information
Date Initiated by Firm September 21, 2015
Date Posted January 06, 2016
Recall Status1 Terminated 3 on October 12, 2016
Recall Number Z-0593-2016
Recall Event ID 72446
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
Product 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.
Code Information Model Number: PIC484, Lot 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;  Model Number: PIC484H, Lot Numbers: 952664, 1023220, 1034517, 1057121, 1084058, 1085156, 1086404, 1115750, 1169297, 1174217, 1182906, 1187568;  Model Number: PIC485, Lot Numbers: 1137568, 1137603, 1176653, 1184855;  Model Number: PIC485H, Lot Numbers: 1113005, 1170171, 1181580; Model Number: PIC654, Lot Numbers: 934480, 950196, 954781, 957204, 961452, 977568, 988996, 1016258, 1024427, 1034516, 048990, 1060550, 1073328, 1073329, 1092256, 1105771, 1115811, 1115812, 1115813, 1115815, 1115816, 1116774; Model Number: PIC654H, Lot Numbers: 970700, 988995, 989022, 1015301, 1043973, 1069114, 1073325, 1073327, 1074848, 1147383, 1166591, 1174216, 1184508, 1184509;  Model Number: PIC655, Lot Numbers: 1040760, 1044047, 1048195, 1115778; Model Number: PIC655H, Lot Numbers: 1031581, 1079916, 973403-S1.     
Recalling Firm/
Manufacturer		 Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information Contact Mark Mashburn
561-776-6700
Manufacturer Reason
for Recall		 Inadequate biocompatibility testing.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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