ProTaper GOLD F1 21mm (2018-08-07)
- Starting date:
- August 7, 2018
- Posting date:
- August 31, 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-67614
Affected products
ProTaper GOLD F1 21mm
Reason
As per Health Hazard Evaluation (HHE-341): Risk level is II as it causes additional/unplanned interventions or corrections during the course of a treatment or after a treatment with no health risk to the patient. There is no long term health impact on the patient. This is a type III recall in Canada.
Affected products
ProTaper GOLD F1 21mm
Lot or serial number
0000173645
Model or catalog number
PTGRF121
Companies
- Manufacturer
-
Dentsply International, Inc.
Dentsply Tulsa Dental Specialties
608 Rolling Hills Drive
Johnson City
37604
UNITED STATES