# FDA recall Z-2132-2026

> **Orthorebirth Co Ltd** · Class II · device recall initiated 2026-03-25.

## Product

ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z

## Reason for recall

Resorbable bone void filler falls outside standard specifications.

## Distribution

US Nationwide distribution in the states of CA, FL.

## Key facts

- **Recall number:** Z-2132-2026
- **Recalling firm:** Orthorebirth Co Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-25
- **Report date:** 2026-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Yokohama, Japan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2132-2026

## Citation

> AI Analytics. FDA recall Z-2132-2026. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-2132-2026. Source: US FDA. Licensed CC0.

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