Class II
Medical Device Recall: OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
IsoTis OrthoBiologics, Inc. · November 27, 2024
Reason for Recall
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
Distribution
US Nationwide distribution in the states of IN, TN & TX.
States Affected
NATIONWIDE
Quantity Affected
22
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0955-2025
Status: ongoing
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