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U.S. Department of Health and Human Services

Class 2 Device Recall Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm

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 Class 2 Device Recall Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mmsee related information
Date Initiated by FirmSeptember 30, 2025
Date PostedNovember 03, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0417-2026
Recall Event ID 97720
510(K)NumberK142115 
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
ProductBrand 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
Code Information Lot Code: Product Catalog Number (SKU#): 70-1047-COM0117 UDI: +D745701047COM01170/$$80176270484/16D20250722E Lot Number: 6270484, 6271089
Recalling Firm/
Manufacturer		 Prismatik Dentalcraft, Inc.
2144 Michelson Dr
Irvine CA 92612-1304
For Additional Information ContactMichelle (Shelly) Gallup
001-949-2223590
Manufacturer Reason
for Recall		 Incorrect titanium screw, packaged with dental implant.
FDA Determined
Cause 2		Employee error
ActionOn 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.
Quantity in Commerce208 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NHA
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