Reported May 14, 2014 · Terminated

AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or…

AlloSource, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: AlloSource, Inc. · 6278 S Troy Cir · Centennial, CO · 80111-6422

Is this the product you have?

  • 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.
Lot codes and dates
    • Lot numbers 132095-603
    • 608
    • 609
    • 611-618
    • 622-629
    • 631-634
    • and 636-638. Lot numbers 132095-604
    • 619
    • and 621
Amount recalled
29

Where it was sold

Why it was recalled

The donor was hemodiluted.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 11, 2014 · Data as of Sep 19, 4:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.