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U.S. Department of Health and Human Services

Class 3 Device Recall LPCCC2: Low Profile Abutment NonHexed Castable Cylinder

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  Class 3 Device Recall LPCCC2: Low Profile Abutment NonHexed Castable Cylinder see related information
Date Initiated by Firm March 14, 2011
Date Posted July 26, 2011
Recall Status1 Terminated 3 on July 27, 2011
Recall Number Z-2884-2011
Recall Event ID 58921
510(K)Number K092341  
Product Classification Definitive Castable Cylinder for Dental Restoration - Product Code NHA
Product LPCCC2: Low Profile Abutment Non-Hexed Castable Cylinder by Biomet 3i

Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast
Code Information Model LPCCC2 Lot# 2010101036 and 2010101037.
Recalling Firm/
Manufacturer		 Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information Contact Alfredo Ferrer
561-776-6700
Manufacturer Reason
for Recall		 Biomet 3i, Palm Beach Gardens, FL is recalling the Model LPCCC2 Low Profile Abutment, Non-Hexed Castable Cylinder, Lots 2010101036 and 2010101037  Exp. 10/2015. Package labeling may not correctly describe the package contents. Product was distributed in Europe only.
FDA Determined
Cause 2		 Labeling mix-ups
Action Biomet 3i sent a "Medical Device Advisory Notice" letter dated February 17, 2011 to all affected customers. The letter described the problem, instructed customers to returned any unused product and to confirm receipt of the notification. For additional information, please contact Customer Service at 800-342-5454.
Quantity in Commerce 232 unit
Distribution Worldwide distribution: http://webapps.cdrh.fda.gov/division-tracking/findTrackable.do?docNum=RCL110656&reviewType=RCL
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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