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