# FDA recall Z-0417-2026

> **Prismatik Dentalcraft, Inc.** · Class II · device recall initiated 2025-09-30.

## Product

Brand Name: Inclusive  Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm  Model/Catalog Number: 70-1047-COM0117

## Reason for recall

Incorrect titanium screw, packaged with dental implant.

## Distribution

US Distribution to states of: California, Colorado, Connecticut, Florida, Georgia, Hawaii, Kentucky, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina, Tennessee, Virginia, Washington.

## Key facts

- **Recall number:** Z-0417-2026
- **Recalling firm:** Prismatik Dentalcraft, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-30
- **Report date:** 2025-11-12

- **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-0417-2026

## Citation

> AI Analytics. FDA recall Z-0417-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0417-2026. Source: US FDA. Licensed CC0.

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