Home / Recalls / Prismatik Dentalcraft, Inc. / Z-0417-2026

Z-0417-2026 Class II Ongoing

Recalled by Prismatik Dentalcraft, Inc. — Irvine, CA

Recall Details

Product Type: Devices
Report Date: November 12, 2025
Initiation Date: September 30, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 208 units

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.

Distribution Pattern

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