Recall Weekly
Moderate riskFDA DeviceClass II

Keystone FP3D Opaque dental resin recalled for possible missing Part B

Keystone Industries recalled FP3D Original Opaque resin cartridges used in dental 3D printing because some may have been filled without Part B resin. If an affected cartridge is used, the resin may look discolored, and printed partial dentures may be less flexible and durable. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Set aside affected cartridges and do not use them to print dentures.
  2. Check for cartridge part number 4220443, UDI H66842204430, and lot 26GP7665 (box part number 4230443).
  3. The notice does not specify a remedy; contact Keystone Industries - Myerstown about the affected lot.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
FP3D Original Opaque; Model/Catalog Number: 4220443; 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
284
Illnesses reported
None reported
Manufactured in
52 King St, Myerstown, Pennsylvania, United States
Classification
Class II
Recall number
Z-0427-2027

In the FDA's words

Description
FP3D Original Opaque; Model/Catalog Number: 4220443; 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. 4230443; Cartridge Part No. 4220443; UDI H66842204430; Lot: 26GP7665; Distribution: Worldwide distribution - US Nationwide and the country of Canada. Affected quantity: 284
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.

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