FDA Medical Device Recalls (openFDA)
Biomet, Inc.: 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.
- Recall number
- Z-1207-2009
- Recalling firm
- Biomet, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2009-03-05
- Posted
- 2009-04-17
- Terminated
- 2009-07-07
- Reason
- A 30 ml tube is packaged with the kit instead of the labeled 60 ml tube.
- 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
- 27 total kits of both products
- Distribution
- Worldwide Distribution -- USA including states of Massachusetts and Minnesota and countries of Germany and Italy.
- Lot, serial or model codes
- REF 800-0611A, Lot Numbers 337920 and 337930 and REF 800-0613A, Lot Number 337890.
- 510(k) numbers
- ["K071934"]
- PMA numbers
- not on file
- Product code
- JQC
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28