Health product recall

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

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

ProFile Vortex Blue

Lot or serial number

0000192175

Model or catalog number

VTB04A1521

Companies
Manufacturer
Dentsply Tulsa Dental Specialties
also trading as Dentsply Endodontics,
608 Rolling Hills Drive
Johnson City
37604
UNITED STATES