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Profile Vortex rotary files (2016-07-07)
- Starting date:
- July 7, 2016
- Posting date:
- July 29, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-59620
Affected products
A. Profile Vortex rotary files
Reason
As per health hazard evaluation (HHE-309) the risk is level III as the health consequence is such that it requires, or has the potential to require medical or surgical intervention. There is no long-term health impact on the patient. Also, additional/unplanned interventions or corrections during the course of a treatment or after a treatment with no health risk to the patient could be experienced. The use of a larger dimension instrument can adversely affect the ability to complete endodontic treatments.
Affected products
A. Profile Vortex rotary files
Lot or serial number
- 0000116559
- 0000117309
Model or catalog number
- PFV042021
- PFV043521
Companies
- Manufacturer
-
Dentsply International, Inc.
Dentsply Tulsa Dental Specialties
608 Rolling Hills Drive
Johnson City
37604
Tennessee
UNITED STATES