Health product recall

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