Inclusive Titanium Screw (Prismatik) – incorrect packaging (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Prismatik Dentalcraft, Inc.
Lot Codes / Batch Numbers
6271089
Products Sold
Lot Code: Product Catalog Number (SKU#): 70-1047-COM0117 UDI: +D745701047COM01170/$$80176270484/16D20250722E Lot Number: 6270484, 6271089
Prismatik Dentalcraft, Inc. is recalling Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4 due to Incorrect titanium screw, packaged with dental implant.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect titanium screw, packaged with dental implant.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, CT, FL, GA, HI, KY, MD, MA, MI, NH, NJ, NY, PA, SC, TN, VA, WA
Page updated: Jan 10, 2026