Health product recall

Bruxzir® Burs

Last updated

Summary

Product
Bruxzir® Burs
Issue
Medical devices - Unauthorised device
What to do

Customers to be contacted. Affected products to be returned to manufacturer.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Bruxzir® Bur Set (Round, Football, Tapered), 3/Pk

More than 10 numbers, contact manufacturer.

Not applicable

Bruxzir® Tapered Bur (021 Mm), 3/Pk

More than 10 numbers, contact manufacturer.

Not applicable

Issue

There is no defect to the products.  Products were sold in Canada that are not licensed for sale in Canada.  This includes a variety of dental products such as burs, abutments, dental screws, impression copying trays, etching kits, dental resins and others.  These also include products manufactured by Myerson, Zest Anchors LLC, Erkodent, Airway Management Inc.and Luxcreo.  Contact Prismatik Dentalcraft for further information.

Recall start date: January 24, 2025

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Dental
Companies
Prismatik Dentalcraft, Inc.(A Wholly Owned Sub. Of Glidewell Lab.)
2144 Michelson Drive, Irvine, California, United States, 92612
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77126

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