---
title: "Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with:... — FDA record Z-0417-2026 | Is It on Recall"
description: "Incorrect titanium screw, packaged with dental implant."
url: https://isitonrecall.com/recall/fda-device-z-0417-2026-brand-name-inclusive-product-name-inclusive-titanium-screw-compatible-with-biomet-3i-certain-3-4-4-1/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm M... — FDA record Z-0417-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 30, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: Incorrect titanium screw, packaged with dental implant.
- **Classification**: Class II
- **Recalling firm**: Prismatik Dentalcraft, Inc.
- **Quantity**: 208 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0417-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0417-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot Code: Product Catalog Number (SKU#): 70-1047-COM0117 UDI: +D745701047COM01170/$$80176270484/16D20250722E Lot Number: 6270484, 6271089 |

Match all identifying details in the current notice. A brand name alone is not enough.

## 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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)
- [Colorado](https://isitonrecall.com/state/colorado/)
- [Connecticut](https://isitonrecall.com/state/connecticut/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Hawaii](https://isitonrecall.com/state/hawaii/)
- [Kentucky](https://isitonrecall.com/state/kentucky/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Maryland](https://isitonrecall.com/state/maryland/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [New Hampshire](https://isitonrecall.com/state/new-hampshire/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [South Carolina](https://isitonrecall.com/state/south-carolina/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Virginia](https://isitonrecall.com/state/virginia/)
- [Washington](https://isitonrecall.com/state/washington/)

## Dates in the source

- **Report date**: Nov 12, 2025
- **Recall initiation date**: Sep 30, 2025
- **Center classification date**: Nov 3, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0417-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Prismatik Dentalcraft, Inc. records](https://isitonrecall.com/brand/prismatik-dentalcraft-inc/)