FDA-Device2025-01-22Class II

OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.

IsoTis OrthoBiologics, Inc.
Hazard

Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.

Sold states
US Nationwide distribution in the states of IN, TN & TX.
Affected count
22
Manufactured in
2 Goodyear Ste A, Irvine, CA, United States
Products
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0955-2025

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