Class II

Medical Device Recall: 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

Prismatik Dentalcraft, Inc. · September 30, 2025

Reason for Recall

Incorrect titanium screw, packaged with dental implant.

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.

Quantity Affected

208 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0417-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Prismatik Dentalcraft, Inc. Medical Device Recall: 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 | SafeCheck