Alpen Carbide 702 Cross Cut Tapered Fissure FG lOpk (Carbide burs) (2018-04-18)
- Starting date:
- April 18, 2018
- Posting date:
- November 30, 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-68512
Affected products
Alpen Carbide 702 Cross Cut Tapered Fissure FG lOpk (Carbide burs)
Reason
Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (P/N r100702), batch number i37460, were labeled as Alpen Carbide 702 Cross Cut Tapered Fissure HP 10pk (P/N r600702). The incorrect labeling affects only a single batch of product, i37460. There is no safety or performance issue with the product.
Affected products
Alpen Carbide 702 Cross Cut Tapered Fissure FG lOpk (Carbide burs)
Lot or serial number
I37460
Model or catalog number
R100702
Companies
- Manufacturer
-
Coltene/Whaledent, Inc.
235 Ascot Parkway
Cuyahoga Falls
44223
Ohio
UNITED STATES