FDA Medical Device Recalls (openFDA)
Prismatik Dentalcraft, Inc.: 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
- Recall number
- Z-0417-2026
- 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
- Status
- Open, Classified
- Initiated
- 2025-09-30
- Posted
- 2025-11-03
- Terminated
- not on file
- Reason
- Incorrect titanium screw, packaged with dental implant.
- 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: 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
- 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.
- Lot, serial or model codes
- Lot Code: Product Catalog Number (SKU#): 70-1047-COM0117 UDI: +D745701047COM01170/$$80176270484/16D20250722E Lot Number: 6270484, 6271089
- 510(k) numbers
- ["K142115"]
- PMA numbers
- not on file
- Product code
- NHA
- Firm FEI
- 3011649314
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28