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
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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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