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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Inc., Biomet Sports Medicine, and Biomet

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  Class 2 Device Recall Biomet Inc., Biomet Sports Medicine, and Biomet see related information
Date Initiated by Firm April 01, 2016
Date Posted May 26, 2016
Recall Status1 Terminated 3 on May 23, 2017
Recall Number Z-1820-2016
Recall Event ID 74038
Product Classification Reamer - Product Code HTO
Product Various trauma and sports medicine instruments and implants.
Reamer.
Code Information Part #'s 41009 110004188 110010579  Lot #'s 668490 756990 757010 757030 758180 
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Audrey Daenzer
574-372-1570
Manufacturer Reason
for Recall		 Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
FDA Determined
Cause 2		 Equipment maintenance
Action Zimmer Biomet sent an Urgent Medical Device Recall Notice dated April 1, 2016, to all affected customers. Customers were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Distribution Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.
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.
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