The FDA has posted 8 enforcement recalls of calcium compound bone void filler devices since 2025, none of them Class I (most serious). Most recent report: Aug 5, 2026.
Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx.…
Resorbable bone void filler falls outside standard specifications.
Resorbable bone void filler falls outside standard specifications.
Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
Due to incorrect product label (Incorrect product name identified on outer packaging).
Vials of implant bone granules may contain less product then specified on labeling.
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Filler, Bone Void, Calcium Compound”). Informational only — verify against the FDA before acting.