Z-0955-2025 Class II Ongoing

Recalled by IsoTis OrthoBiologics, Inc. — Irvine, CA

Recall Details

Product Type
Devices
Report Date
January 22, 2025
Initiation Date
November 27, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22

Product Description

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 Pattern

US Nationwide distribution in the states of IN, TN & TX.

Code Information

UDI-DI: 10889981055820, Lot 1031907, Exp. 2025-11-28 (Inner Tray Exp. 2024-11-28) and Lot 1031825, Exp. 2025-07-28 (Inner tray Exp. 2025-03-28)