Class 3 Device Recall BIOMET 3i Locator Abutment

• Date Initiated by Firm: February 07, 2008
• Create Date: June 25, 2015
• Recall Status: Terminated on July 10, 2008
• Recall Number: Z-1364-2008
• Recall Event ID: 47340
• Product Classification: Locator Abutment - Product Code DZE
• Product: BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA003, 3.0mm, BioMet 3i , Palm Beach, FL.
• Code Information: Lot Number: 765295
• 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: 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: 97
• 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.