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.
FDA Recall Z-1207-2009 · Posted 2009-04-17
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeJQC
Date Initiated2009-03-05
Date Terminated2009-07-07
Product Quantity27 total kits of both products
Reason for Recall
A 30 ml tube is packaged with the kit instead of the labeled 60 ml tube.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- USA including states of Massachusetts and Minnesota and countries of Germany and Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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