IsoTis OrthoBiologics, Inc. recalls OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc,…
- Recall date
- November 27, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0955-2025
- FDA classification
- Class II
- Brand / firm
- IsoTis OrthoBiologics, Inc.
- Sold / distributed
- US Nationwide distribution in the states of IN, TN & TX.
Why it was recalled
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
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