Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1562-2014 — 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.

U.S. FDA — Device Enforcement · United States · 2014-03-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1562-2014
Date of alert: 2014-03-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: AlloSource, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 90038005

Reported risk: The donor was hemodiluted.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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