Z-1207-2009

Biomet Marrowstim Concentration Kit w/single Disposable Separator, Bone Marrow Needle, and 30 ml ACD-A. For...

Name: Z-1207-2009 Biomet Marrowstim Concentration Kit w/single Disposable Separator, Bone Marrow Needle, and 30 ml ACD-A. For...
Creator: Biomet, Inc.
Published: 2009-03-05
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-03-05 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Biomet Marrowstim Concentration Kit w/single Disposable Separator, Bone Marrow Needle, and 30 ml ACD-A. For use with BBI centrifuges only, sterile, Biomet... on 2009-03-05. The reason FDA records is "A 30 ml tube is packaged with the kit instead of the labeled 60 ml tube". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1207-2009
Status: Terminated
Initiated: 2009-03-05
Posted: 2009-04-17
Terminated: 2009-07-07
Recalling firm: Zimmer GmbH
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.
Product code: JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Reason for recall: A 30 ml tube is packaged with the kit instead of the labeled 60 ml tube.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: REF 800-0611A, Lot Numbers 337920 and 337930 and REF 800-0613A, Lot Number 337890.

Product code JQC

K071934Class IMarrowstim Concentration Kit and Marrowstim Mini Concentration KitBiomet Manufacturing Corp / cleared 2007-10-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)