Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain...
FDA Recall #Z-0417-2026 — Class II — September 30, 2025
Product Description
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.
Recalling Firm
Prismatik Dentalcraft, Inc. — Irvine, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
208 units
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.
Code Information
Lot Code: Product Catalog Number (SKU#): 70-1047-COM0117 UDI: +D745701047COM01170/$$80176270484/16D20250722E Lot Number: 6270484, 6271089
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated