Medical device recalls Moderate risk

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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