# FDA recall Z-2820-2026

> **IsoTis OrthoBiologics, Inc.** · Class II · device recall initiated 2026-07-02.

## Product

OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095.  Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095

## Reason for recall

Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 ¿ 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 ¿ 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.

## Distribution

US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.

## Key facts

- **Recall number:** Z-2820-2026
- **Recalling firm:** IsoTis OrthoBiologics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-07-02
- **Report date:** 2026-08-05

- **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-2820-2026

## Citation

> AI Analytics. FDA recall Z-2820-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2820-2026. Source: US FDA. Licensed CC0.

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