AlloSource Recalls AlloFuse DBM Putty Due to Donor Hemodilution
AlloSource, Inc. is recalling 29 units of AlloFuse DBM Putty 5cc because the donor was hemodiluted. The product is used as a bone graft extender in orthopedic applications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, a Class II recall without explicit reports of hospitalization or significant injury falls under the 'High' severity category, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
AlloSource, Inc. is recalling 29 units of AlloFuse DBM Putty 5cc, Catalog No. 90038005. The recall was initiated because the donor for the product was hemodiluted. AlloFuse is indicated for orthopedic applications as a filler for gaps or voids in the skeletal system that are not intrinsic to the stability of the bony structure, serving as a bone graft extender.
The affected lot numbers are 132095-603, 608, 609, 611-618, 622-629, 631-634, and 636-638, as well as 132095-604, 619, and 621. The product was distributed nationwide in the United States, including Michigan and a distributor in Colorado.
Healthcare providers and patients should stop using the affected product and contact AlloSource, Inc. for further instructions. The FDA has classified this recall as Class II, which means the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- 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…
- Manufacturer
- AlloSource, Inc.
- Hazard
- Affected units
- 29
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot numbers 132095-603
- 608
- 609
- 611-618
- 622-629
- 631-634
- and 636-638. Lot numbers 132095-604
- 619
- and 621.
Distribution
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