FDA recall Z-0955-2025

IsoTis OrthoBiologics, Inc. · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-11-27
Report date
2025-01-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irvine, CA, United States

Primary source

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