Keystone FP3D dental resin recalled for possible missing Part B
Some FP3D resin cartridges may have been filled without Part B resin. If an affected cartridge is used, the resin may look discolored when dispensed or after post-curing, and printed partial denture parts may be less flexible and durable. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Do not use affected cartridges to print partial dentures. Affected products are FP3D Light Reddish Pink, box part number 4230441, cartridge part number 4220441, UDI H66842204410, all lots.
- Contact Keystone Industries. The notice doesn't say how to get a replacement or refund.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- FP3D Light Reddish Pink; Model/Catalog Number: 4230441; Product Description: The FP3D is designed for additive manufacturing on Carbon 3D printers (wavelength = 385 nm). FP3D is intended to be used within a computer-aided design and manufacturing (CAD/CAM) digital dentistry system that includes a 3D scanner, design software, 3D printer, post-cure unit (wavelength = 385-405 nm), and post-cure oven for the fabrication of flexible partial dentures for partially edentulous patients. The device is manufactured using dual-cure technology. The resin consists of two parts (Part A and Part B) that are mixed just before printing. Part A is a UV-curable resin, and Part B is a cross-linking diamine agent. When mixed, the resin undergoes free radical polymerization initiated by a photo-initiator in the presence of a UV light source during the 3D printing process. After printing, the device is then thermally cured in an oven to complete polymerization.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 4 products — see all of them.
Details
- Units affected
- 320
- Illnesses reported
- None reported
- Manufactured in
- 52 King St, Myerstown, Pennsylvania, United States
- Classification
- Class II
- Recall number
- Z-0424-2027
In the FDA's words
- Description
- FP3D Light Reddish Pink; Model/Catalog Number: 4230441; Product Description: The FP3D is designed for additive manufacturing on Carbon 3D printers (wavelength = 385 nm). FP3D is intended to be used within a computer-aided design and manufacturing (CAD/CAM) digital dentistry system that includes a 3D scanner, design software, 3D printer, post-cure unit (wavelength = 385-405 nm), and post-cure oven for the fabrication of flexible partial dentures for partially edentulous patients. The device is manufactured using dual-cure technology. The resin consists of two parts (Part A and Part B) that are mixed just before printing. Part A is a UV-curable resin, and Part B is a cross-linking diamine agent. When mixed, the resin undergoes free radical polymerization initiated by a photo-initiator in the presence of a UV light source during the 3D printing process. After printing, the device is then thermally cured in an oven to complete polymerization. Some resin cartridges may have been filled without Part B resin. If an affected cartridge is used, the resin may look discolored when dispensed or after post-curing and printed parts may be less flexible and durable. Box Part No. 4230441; Cartridge Part No. 4220441; UDI H66842204410; All lots; Distribution: Worldwide distribution - US Nationwide and the country of Canada. Affected quantity: 320
- Hazard
- Some resin cartridges may have been filled without Part B resin. If an affected cartridge is used, the resin may look discolored when dispensed or after post-curing and printed parts may be less flexible and durable.
4 products in this recall
Keystone FP3D resin recalled for possible missing Part B
Keystone Industries is recalling four FP3D resin cartridges for Carbon 3D printers: FP3D Light Reddish Pink, FP3D Dark Veined, FP3D Original Pink and FP3D Original Opaque. Some cartridges may have been filled without Part B resin. If an affected cartridge is used, the resin may look discolored, and printed parts may be less flexible and durable.
The agency lists each product separately. Check every one you might have.
- FP3D Light Reddish Pink;
Model/Catalog Number: 4230441;
Product Description: The FP3D is designed for additive manufacturing on Carbon 3D printers (wavelen… (this page)Z-0424-2027 · 320
- FP3D Dark Veined;
Model/Catalog Number: 4220442
Product Description: The FP3D is designed for additive manufacturing on Carbon 3D printers (wavelength = 38…Z-0425-2027 · 210
- FP3D Original Pink;
Model/Catalog Number: 4220440;
Product Description: The FP3D is designed for additive manufacturing on Carbon 3D printers (wavelength =…Z-0426-2027 · 1112
- FP3D Original Opaque;
Model/Catalog Number: 4220443;
Product Description: The FP3D is designed for additive manufacturing on Carbon 3D printers (wavelength…Z-0427-2027 · 284