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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