Prismatik Dentalcraft, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0417-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: September 30, 2025

Date Posted: November 12, 2025

Recall Number: Z-0417-2026

Event ID: 97720

Reason for Recall:

Incorrect titanium screw, packaged with dental implant.

Status: Ongoing

Product Quantity: 208 units

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated