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
- Company
- Prismatik Dentalcraft, Inc
- Recall Initiated
- September 30, 2025
- Posted
- November 3, 2025
- Recall Number
- Z-0417-2026
- Quantity
- 208 units
- Firm Location
- Irvine, CA
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.
Lot / Code Info
Lot Code: Product Catalog Number (SKU#): 70-1047-COM0117 UDI: +D745701047COM01170/$$80176270484/16D20250722E Lot Number: 6270484, 6271089
Root Cause
Employee error
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.