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U.S. Department of Health and Human Services

Class 3 Device Recall MARROWSTIM CONCENTRATION KIT & MARROWSTIM MINI CONCENTRATION KIT

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  Class 3 Device Recall MARROWSTIM CONCENTRATION KIT & MARROWSTIM MINI CONCENTRATION KIT see related information
Date Initiated by Firm March 05, 2009
Date Posted April 17, 2009
Recall Status1 Terminated 3 on July 07, 2009
Recall Number Z-1207-2009
Recall Event ID 51316
510(K)Number K071934  
Product Classification Centrifuges (micro, ultra, refrigerated) for clinical use - Product Code JQC
Product Biomet Marrowstim Concentration Kit w/single Disposable Separator, Bone Marrow Needle, and 30 ml ACD-A. For use with BBI centrifuges only, sterile, Biomet Biologics, Warsaw, IN; REF 800-0611A and 800-0613A.

The device is used for the rapid preparation of platelet-poor-plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.
Code Information REF 800-0611A, Lot Numbers 337920 and 337930 and REF 800-0613A, Lot Number 337890.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
For Additional Information Contact
800-372-3983
Manufacturer Reason
for Recall		 A 30 ml tube is packaged with the kit instead of the labeled 60 ml tube.
FDA Determined
Cause 2		 Process control
Action Consignees were notified by "URGENT MEDICAL DEVICE REMOVAL NOTICE " dated March 5, 2009 and instructed to locate and return the recalled products. Direct questions about this recall to Biomet Orthopedics at 1-800-348-9500 or 574-372-3983, Monday through Friday, 8AM to 5PM.
Quantity in Commerce 27 total kits of both products
Distribution Worldwide Distribution -- USA including states of Massachusetts and Minnesota and countries of Germany and Italy.
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.
510(K) Database 510(K)s with Product Code = JQC and Original Applicant = BIOMET MANUFACTURING CORP.
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