—#79805

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.

FDA product code: JQC — Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K071934
Affected lot / code info: REF 800-0611A, Lot Numbers 337920 and 337930 and REF 800-0613A, Lot Number 337890.

Why it was recalled

A 30 ml tube is packaged with the kit instead of the labeled 60 ml tube.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582

Distribution

Distribution pattern: Worldwide Distribution -- USA including states of Massachusetts and Minnesota and countries of Germany and Italy.

Timeline

Recall initiated: 2009-03-05
Posted by FDA: 2009-04-17
Terminated: 2009-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #79805. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.