RegWardenFDA facility compliance records
Recall

Class II — AlloSource, Inc.

Recalling firmAlloSource
Registered facilityALLOSOURCE (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonThe donor was hemodiluted.
ProductAlloFuse 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.
Quantity29
DistributionDistribution US nationwide, including Michigan and a distributor in Colorado.
Initiated2014-03-25
Classified2014-05-06
Terminated2014-08-11
Recall numberZ-1562-2014
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — AlloSource, Inc. (Z-1562-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67986/

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