EdgeOne Fire (Sterile)
Brand(s)
Last updated
Summary
Product
EdgeOne Fire (Sterile)
Issue
Medical devices - Sterility
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Industry
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
EdgeOne Fire (Sterile) |
032924052 |
SEOFGP21 |
Issue
The manufacturer US Endodontics, LLC., has recalled certain lots of sterile EdgeOne Fire GlidePath distributed between May 03, 2024 through May 17, 2024. This recall is initiated as during an evaluation of internal validations, it was identified that the devices in question were irradiated above the established max dose.
Recall Start Date: November 22, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Dental
Companies
US Endodontics
2809 W. Walnut St., Johnson City, Tennessee, United States, 37604
Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-76601
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