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U.S. Department of Health and Human Services

Class 3 Device Recall BIOMET 3i Locator Abutment

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  Class 3 Device Recall BIOMET 3i Locator Abutment see related information
Date Initiated by Firm February 07, 2008
Create Date June 25, 2015
Recall Status1 Terminated 3 on July 10, 2008
Recall Number Z-1363-2008
Recall Event ID 47340
510(K)Number K012911  
Product Classification Locator Abutment - Product Code DZE
Product BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA002, 2.0mm, BioMet 3i, Palm Beach, FL.
Code Information Lot Number: 765291
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		 Mispackaging: The Locator Abutment labeled as LOA002 may contain Catalog/Item # LOA003 product and visa versa
FDA Determined
Cause 2		 Other
Action Each USA customer was contacted by telephone and then by letter, Urgent Medical Device Recall, dated 2/15/2008, sent by fax. International customers were first contacted by E-mail then by fax letter also. 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 for product return. They were also instructed to return the affected product to Biomet 3i.
Quantity in Commerce 100
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 = DZE and Original Applicant = IMPLANT INNOVATIONS, INC.
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