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U.S. Department of Health and Human Services

Class 2 Device Recall Elbow Humeral Trial

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  Class 2 Device Recall Elbow Humeral Trial see related information
Date Initiated by Firm September 24, 2014
Date Posted October 16, 2014
Recall Status1 Terminated 3 on July 14, 2015
Recall Number Z-0075-2015
Recall Event ID 69340
Product Classification Template - Product Code HWT
Product Discovery Elbow Humeral Trial

Product Usage:
Biomet manufactures a variety of elbow joint replacement prostheses intended for primary and revision joint arthoplasty for use in cemented applications. Elbow joint replacement components include humeral and ulnar components, and in some instances, hinge components.
Code Information Catalog Number: 414837 Lot Number: 555011
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46581
For Additional Information Contact Audrey Daenzer
574-372-1570
Manufacturer Reason
for Recall		 An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.
FDA Determined
Cause 2		 Process control
Action Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letters dated September 24, 2014, via FedEx overnight to affected customers. The notification included a description of the reason for recall, instructions for responding to the formal recall notification, and affected product, actions to be taken. For questions call (574) 372-1570.
Quantity in Commerce 6
Distribution Worldwide Distribution - US Nationwide in the state of SD, OH, CT and the country of: The Netherlands and India.
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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