IsoTis OrthoBiologics, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0955-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 27, 2024

Date Posted: January 22, 2025

Recall Number: Z-0955-2025

Event ID: 95981

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.

Status: Ongoing

Product Quantity: 22

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)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated