# FDA recall Z-0919-2025

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

## Product

OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.

## Reason for recall

Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.

## Distribution

US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.

## Key facts

- **Recall number:** Z-0919-2025
- **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-0919-2025

## Citation

> AI Analytics. FDA recall Z-0919-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0919-2025. Source: US FDA. Licensed CC0.

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