Biomet Marrowstim Concentration Kit w/single Disposable Separator, Bone Marrow Needle, and 30 ml ACD-A. For use with BBI
FDA device recall Z-1207-2009 · posted 2009-04-17 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- A 30 ml tube is packaged with the kit instead of the labeled 60 ml tube.
- Action taken
- 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
- Status
- Terminated
- Product code
- JQC
- Quantity affected
- 27 total kits of both products
- Distribution
- Worldwide Distribution -- USA including states of Massachusetts and Minnesota and countries of Germany and Italy.
- Date initiated
- 2009-03-05
- Date posted
- 2009-04-17
- Date terminated
- 2009-07-07
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT (K071934) | Biomet Manufacturing Corp | 2007-10-11 |