# FDA recall Z-0955-2025

> **IsoTis OrthoBiologics, Inc.** · Class II · device recall initiated 2024-11-27.

## 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

- **Recall number:** Z-0955-2025
- **Recalling firm:** IsoTis OrthoBiologics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-27
- **Report date:** 2025-01-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0955-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0955-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*