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U.S. Department of Health and Human Services

Class 2 Device Recall Certain LowProfile, Angled Abutment

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  Class 2 Device Recall Certain LowProfile, Angled Abutment see related information
Date Initiated by Firm January 10, 2012
Date Posted April 25, 2012
Recall Status1 Terminated 3 on April 30, 2012
Recall Number Z-1456-2012
Recall Event ID 61473
510(K)Number K092341  
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
Product Certain Low-Profile, Angled Abutment, Model Number ILPAC3217. Product is labeled in part: "***Biomet 3i***4555 Riverside Drive , Palm Beach Gardens, FL 33410 USA***REF ILPAC3217***LOT 2011091179***Certain Low Profile 17 Abutment***3.4mm(D) X 2mm(H)***Abutment:; Pillar; Abutment; Abutment; Pilastro; Pillar***CE dose***Use by 2016-09***Sterile using Radiation***RX Only***Do not reuse***Consult accompanying documents***Do not re-sterilize***Do not use if package is damaged***ILPAC3217***2011091179***"P-LBLNY3P***Rev. D***".

Intended to provide a means to attach crown restorations or implant frameworks to implants.
Code Information Lot Numbers: 2011060659, 2011070773, 2011070988, 2011071332, 2011071575, 2011080241, 2011080697, and 2011091179.
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		 Biomet 3i initiated a recall for a small percentage of the 33mm (ILPAC3217) abutment packages that may contain the 5mm (ILPAC5217) abutment.
FDA Determined
Cause 2		 Material/Component Contamination
Action Biomet 3i , LLC sent Urgent: Medical Device Recall notices on 1/10/2012 to each customer in via e-mail, facsimile, telephone or postal mail. The letters identified the affected product and the reason for the recall. Each customer was instructed to check their respective inventory for the affected product and return any unused product to Biomet 3i at the address provided. Biomet 3i will issue replacement product at no charge. Questions or concerns should be directed to 1-800-342-5454.
Quantity in Commerce 400
Distribution Worldwide Distribution -- Canada, Chile, Columbia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Singapore, South Africa, Spain, Sweden, Switzerland, UK, US, and Vietnam.
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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