ProFile Vortex Blue (2018-09-24)

Starting date:

September 24, 2018

Posting date:

October 19, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67940

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  Reason
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  Affected products

Affected products

ProFile Vortex Blue

Reason

The size 40/.04 21 MM file in the assortment pack contained an incorrect blade in the 40/.04 handle: actual blade was a Vortex Blue 15:.06 21 MM. The 15/.06 tile blade is smaller and can potentially prevent the physical cleaning of the apical dentinal area. This could potentially result in the need to spend additional unplanned time and instruments with a larger diameter to complete the procedure.

Affected products