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U.S. Department of Health and Human Services

Class 3 Device Recall Biomet Graft Preparation System

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  Class 3 Device Recall Biomet Graft Preparation System see related information
Date Initiated by Firm June 11, 2007
Date Posted July 04, 2007
Recall Status1 Terminated 3 on December 05, 2007
Recall Number Z-0994-2007
Recall Event ID 38116
Product Classification bone graft preparation syringe - Product Code FMF
Product Vortech Graft Preparation System, sterile, single use, disposable, Distributed by Biomet Biologics, Inc., Warsaw, Indiana; REF 800-0300V. (Not sold in the United States).
Code Information Lot 192380, exp. Jan 2012.
Recalling Firm/
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46581-0587
For Additional Information Contact
Manufacturer Reason
for Recall
The syringe assembly has an obstruction in the tube that prevents the plunger from being depressed.
FDA Determined
Cause 2
Action Consignees were notified by letter dated either 6/11/07 or 6/13/07 and requested to return the product.
Quantity in Commerce 5 to Europe
Distribution Worldwide, including USA, Chile, Italy, Spain and United Kingdom.
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.