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Health product recall

Carbide Cutting Burrs (2013-12-19)

Starting date:
December 19, 2013
Posting date:
March 18, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-38279

Recalled Products

Carbide Cutting Burrs 

Reason

The laser marking location is out of specification which causes it to align with the distal bearing of the attachment and can lead to a potential cutting Bur fracture.

Affected products

A. Bur - Carbide Fluted Ball, Standard

Lot or serial number

C073015750
C163019559
C293023851
C433027411
E193049913
F456011604
G043074760

Model or catalog number

S-2SB-C
S-2SB-C
S-3SB-C
S-3SB-C

Companies
Manufacturer
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES

B. Bur - Carbide Fluted Ball

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

More than 10 numbers, contact manufacturer

Companies
Manufacturer
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES