# FDA recall Z-0540-2026

> **Berkeley Advanced Biomaterials, LLC** · Class II · device recall initiated 2025-09-02.

## Product

Tribio Implant 7.5mm x 40mm REF M80 SB008  UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630    Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure.

## Reason for recall

Due to incorrect product label (Incorrect product name identified on outer packaging).

## Distribution

U.S. Nationwide distribution in the state of TN.

## Key facts

- **Recall number:** Z-0540-2026
- **Recalling firm:** Berkeley Advanced Biomaterials, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-02
- **Report date:** 2025-11-26

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0540-2026

## Citation

> AI Analytics. FDA recall Z-0540-2026. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-0540-2026. Source: US FDA. Licensed CC0.

---

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