Z-0417-2026Class II

Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain...

Name: Z-0417-2026 Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain...
Creator: Prismatik Dentalcraft, Inc.
Published: 2025-09-30
License: https://open.fda.gov/license/

Prismatik Dentalcraft, Inc. / initiated 2025-09-30 / Open, Classified / root cause: manufacturing process

FDA source

Prismatik Dentalcraft, Inc. began a recall of 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 on 2025-09-30. FDA classified it as Class II and gives the reason as "Incorrect titanium screw, packaged with dental implant". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0417-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-30
Posted: 2025-11-03
Recalling firm: Prismatik Dentalcraft, Inc.
Product: 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 code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: Incorrect titanium screw, packaged with dental implant.
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 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.
Product codes and lots: Lot Code: Product Catalog Number (SKU#): 70-1047-COM0117 UDI: +D745701047COM01170/$$80176270484/16D20250722E Lot Number: 6270484, 6271089

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0417-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0417-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-12	2025-11-03

Product code NHA

K142115Class IIInclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc. / cleared 2014-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)