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
FDA Recall Z-0417-2026 · Posted 2025-11-03
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Recalling FirmPrismatik Dentalcraft, Inc.
Recall StatusOpen, Classified
Product CodeNHA
Date Initiated2025-09-30
Product Quantity208 units
Reason for Recall
Incorrect titanium screw, packaged with dental implant.
Firm 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 this recall and the content within this letter.
3. Please discontinue use and if you have any inventory in storage, please return the product to receive a credit, using the return form attached with the specific contact information to: [email protected].
3. Please complete the form, sign, date, and return the form to [email protected].
4. Please make a copy of the signed form and place it with the returning product.
If you any further questions, contact SVP of RA/QA at 949-222-3590.
Root Cause
Employee error
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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