Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Mode

FDA device recall Z-0417-2026 · posted 2025-11-03 · Open, Classified

Recall details

Recalling firm

Prismatik Dentalcraft, Inc.

Reason for recall

Incorrect titanium screw, packaged with dental implant.

Action taken

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: RA.Mailbox@glidewelldental.com. 3. Please complete the form, sign, date, and return the form to RA.Mailbox@glidewelldental.com. 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

Status

Open, Classified

Product code

NHA

Quantity affected

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 Carolin

Date initiated

2025-09-30

Date posted

2025-11-03

Location

Irvine, CA

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