Device product
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.
Z-1562-2014
Product summary
- Firm
- AlloSource, Inc.
- Event
- Event 67986
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29
- Official record key
device-enforcement:Z-1562-2014
Official wording
Reason: The donor was hemodiluted.
Code information: Lot numbers 132095-603, 608, 609, 611-618, 622-629, 631-634, and 636-638. Lot numbers 132095-604, 619, and 621.
Distribution pattern: Distribution US nationwide, including Michigan and a distributor in Colorado.
Derived failure modes
-
Unknown
The donor was hemodiluted.