Health product recall

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