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U.S. Department of Health and Human Services

Class 2 Device Recall LOW PROFILE ABUTMENTS INTERNAL AND EXTERNAL CONNECTION

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  Class 2 Device Recall LOW PROFILE ABUTMENTS INTERNAL AND EXTERNAL CONNECTION see related information
Date Initiated by Firm September 14, 2016
Create Date December 20, 2016
Recall Status1 Terminated 3 on July 26, 2019
Recall Number Z-0830-2017
Recall Event ID 75761
510(K)Number K092341  
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
Product BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Code Information Part # ILPAC3530 Lot # 2016030311
Recalling Firm/
Manufacturer		 Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information Contact Customer Service
800-348-2759
Manufacturer Reason
for Recall		 A limited number of product pouches may not have been sealed during packaging.
FDA Determined
Cause 2		 Employee error
Action BIOMET 3i will conduct this recall with Dentists and Health Care Professionals. Notices will be sent via a carrier with a traceable method of delivery by BIOMET 3i team members. " All dentists and health care professionals will be notified via courier: - Dentists and health care professionals will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their control. - Dentists and health care professionals will return on-hand product to BIOMET 3i via a courier agency and ensure all of their products are accounted for using the form provided in the letter. - Dentists and health care professionals will complete and return the Inventory Return Certification Form to the fax number or email address provided. International distributors will be notified via email. Further distribution of the international customer notices will be sent through the local and regional distributors following local language translation. Communications will occur as translations are completed and are anticipated to occur during the week of September 12, 2016.1233. Customers with questions were instructed to call the customer call center at +44 (0) 800 652-1233.
Quantity in Commerce 27
Distribution Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden
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.
510(K) Database 510(K)s with Product Code = NHA and Original Applicant = BIOMET 3I, INC.
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