Health product recall

FP3D™ Resins

Last updated

Summary

Product
FP3D™ Resins
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare
Industry

Affected products

Affected products

Lot or serial number

Model or catalogue number

FP3D™ Light Reddish Pink

26AP7191

4230441

FP3D™ Original Pink

25GP6826

4230440

FP3D™ Dark Veined

25IP6936

4230442

FP3D™ Original Opaque

26GP7665

4230443

Issue

FP3D™ is a dual cure resin indicated for the 3D printed fabrication of flexible partial dentures in dental laboratories. Each unit is supplied in a 10:1 resin cartridge containing part a resin and part b resin. FP3D™ resin bottles may have been mis-filled during the manufacturing process and inadvertently shipped without part B resin.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Dental
Companies

Keystone Industries

52 West King Street, Myerstown, Pennsylvania, United States, 17067

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Recall date
Identification number
RA-82839

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