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U.S. Department of Health and Human Services

Class 2 Device Recall Low Profile Abutment

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 Class 2 Device Recall Low Profile Abutmentsee related information
Date Initiated by FirmMay 31, 2012
Date PostedAugust 24, 2012
Recall Status1 Terminated 3 on November 21, 2013
Recall NumberZ-2271-2012
Recall Event ID 62578
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
ProductLow Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing without prescription***Consult instructions for use*** Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast.
Code Information Lots: 2010100001, 2010080684, and 2010090191
FEI Number 1038806
Recalling Firm/
Manufacturer		 Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information ContactMark Mashburn
561-776-6700
Manufacturer Reason
for Recall		Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due to some packages labeled LPCCC1, Hexed Castable Cylinder possibly containing LPCCC2, Non-Hexed Castable Cylinders.
FDA Determined
Cause 2		Labeling mix-ups
ActionBiomet 3i sent a "MEDICAL DEVICE ADVISORY NOTICE" dated May 31, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-342-5454 for questions regarding this recall.
Quantity in Commerce611 units
DistributionWorldwide Distribution-Distributed in the USA and the countries to Spain, France, Germany, Switzerland, and Australia.
Total Product Life CycleTPLC 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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