Recall Z-0417-2026 ยท NHA Abutment, Implant, Dental, Endosseous
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
| Date | Nov 3, 2025 (initiated Sep 30, 2025) |
| Status | Open, Classified |
| Reason | Incorrect titanium screw, packaged with dental implant. |
| Root cause | Employee error |
| Action | On September 30, 2025, Prismatik Dentalcraft, Inc. issued an "Urgent: Voluntary Medical Deice Recall" Notification via Fed-Ex to affected consignees. Prismatik asked consignees to take the following actions: 1. Please review your inventory for the affected product received between 07/25/2025 through 08/07/2025. If you have any product remaining in inventory with an incorrect finished device, please collect and quarantine for return. 2. Please notify personnel within your organization and notify all customers where the affected products may have been transferred or further distributed to thi |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142115 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT Prismatik Dentalcraft, Inc., Nov 13, 2014 |