Medical device recalls Moderate risk

Prismatik Dentalcraft, Inc. recalls Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Mod…

Recall date
September 30, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0417-2026
FDA classification
Class II
Brand / firm
Prismatik Dentalcraft, Inc.
Sold / distributed
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.

Why it was recalled

Incorrect titanium screw, packaged with dental implant.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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