# FDA recall Z-1038-2026

> **Medicrea International** · Class II · device recall initiated 2025-10-29.

## Product

Medicrea, IB3D Universal Implant Inserter, Rx Only  REF: A24000000

## Reason for recall

Due to complaints, orthopedic  rotation tool handle may untread from the shaft resulting in the inability to rotate implant.

## Distribution

US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.

## Key facts

- **Recall number:** Z-1038-2026
- **Recalling firm:** Medicrea International
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-29
- **Report date:** 2026-01-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rillieux La Pape, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1038-2026

## Citation

> AI Analytics. FDA recall Z-1038-2026. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-1038-2026. Source: US FDA. Licensed CC0.

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