AlloFuse DBM Putty 5cc — Class II medical device recall Z-1562-2014
Terminated recall by AlloSource, Inc., reported 2014-05-14, distributed nationwide. The donor was hemodiluted.
| Recall number | Z-1562-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AlloSource, Inc., Centennial, CO, United States |
| Recall initiated | 2014-03-25 |
| Classified | 2014-05-06 |
| Reported by FDA | 2014-05-14 |
| Terminated | 2014-08-11 |
| Distributed | Nationwide (US) |
| Quantity | 29 |
| Lot numbers | 132095-603, 132095-604, 608, 609, 611-618, 619, 621, 622-629, 631-634, 636-638 |
| Model numbers | 90038005 |
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.
Reason for recall
The donor was hemodiluted.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1562-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.