Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Recalled by Prismatik Dentalcraft, Inc. Due to Incorrect titanium screw, packaged with dental implant.

Date: September 30, 2025
Company: Prismatik Dentalcraft, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Prismatik Dentalcraft, Inc. directly.

Affected Products

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

Quantity: 208 units

Why Was This Recalled?

Incorrect titanium screw, packaged with dental implant.

Where Was This Sold?

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.

About Prismatik Dentalcraft, Inc.

Prismatik Dentalcraft, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report