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U.S. Department of Health and Human Services

Class 3 Device Recall Certain MicroMiniplant Straight Healing Abutment

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  Class 3 Device Recall Certain MicroMiniplant Straight Healing Abutment see related information
Date Initiated by Firm February 06, 2008
Date Posted March 28, 2008
Recall Status1 Terminated 3 on July 07, 2008
Recall Number Z-1365-2008
Recall Event ID 47341
510(K)Number K072642  
Product Classification Healing Abutment - Product Code NHA
Product BIOMET 3i Certain MicroMiniplant Straight Healing Abutment, Model/Item Number: ISMHA32, 3.4mm(D) X 0mm(P) X 2mm(H), BioMet 3i, Palm Gardens, FL.
Code Information Lot Number: 593025-5
Recalling Firm/
Manufacturer		 Biomet 3i, Inc.
4555 Riverside Drive
Palm Beach Gardens FL 33410
For Additional Information Contact
561-776-6700 Ext. 6819
Manufacturer Reason
for Recall		 Seating Problems: The Micro-miniplant Straight Healing Abutments do not fully seat onto the restorative platform of the implant leaving a gap between the abutment and the implant.
FDA Determined
Cause 2		 Device Design
Action USA customers were contacted by telephone with a follow-up fax. International customers were first contacted by E-mail then by fax letter. Each customer was instructed to check their respective inventory for the affected part and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affected product to Biomet 3i.
Quantity in Commerce 270
Distribution Worldwide
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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