Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Mo
Summary
The FDA issued a Class II for Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: B by Prismatik Dentalcraft, Inc.. Reason: Incorrect titanium screw, packaged with dental implant..
Details
Source
Device Recall
External ID
Z-0417-2026
Action Date
2025-11-12
Status
Ongoing
Category
device
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
Lot/Code Info: Lot Code: Product Catalog Number (SKU#): 70-1047-COM0117 UDI: +D745701047COM01170/$$80176270484/16D20250722E Lot Number: 6270484, 6271089
Quantity Affected: 208 units
Reason for Recall
Incorrect titanium screw, packaged with dental implant.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-30
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 185 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Prismatik Dentalcraft, Inc. has 26 FDA actions in our database, including 2 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Prismatik Dentalcraft, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Prismatik Dentalcraft, Inc. have FDA actions?
Prismatik Dentalcraft, Inc. has 26 FDA actions in our database, including 2 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0417-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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