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Class 3 Device Recall BIOMET 3i Locator Abutment |
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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
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Product Classification |
Locator Abutment - Product Code DZE
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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
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For Additional Information Contact |
561-776-6700 Ext. 6819
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Manufacturer Reason for Recall |
Mispackaging: The Locator Abutment labeled as LOA002 may contain Catalog/Item # LOA003 product and visa versa
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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
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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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510(K) Database |
510(K)s with Product Code = DZE and Original Applicant = IMPLANT INNOVATIONS, INC.
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