FDAFDA · Food and drugs·Recall number Z-1562-2014
AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender.
Published May 14, 2014 · Recall initiated: March 25, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The donor was hemodiluted.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AlloSource, Inc.
- Distributor
- Distribution US nationwide, including Michigan and a distributor in Colorado.
- Lot
- Lot numbers 132095-603, 608, 609, 611-618, 622-629, 631-634, and 636-638. Lot numbers 132095-604, 619, and 621.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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