FDAHealthSeptember 30, 2025

Prismatik Dentalcraft, Inc. — 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

⚠️ Incorrect titanium screw, packaged with dental implant.

Is this relevant to me?

Geography: US
Source agency: FDA
Category: Health
Published: September 30, 2025

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.

What's affected?

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
Brand: Prismatik Dentalcraft, Inc.
Lot code: Product

Additional details

Lot Code: Product Catalog Number (SKU#): 70-1047-COM0117 UDI: +D745701047COM01170/$$80176270484/16D20250722E Lot Number: 6270484, 6271089

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 208 units.

View original FDA notice →

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