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Health product recall

Profile Series 29 Hand File (2014-04-09)

Starting date:
April 9, 2014
Posting date:
May 5, 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-39315

Recalled Products

Profile Series 29 Hand File

Reason

Mislabelled product: Packs are labelled as a SF063006 (30 mm length) but contained SF062506 (25 mm length). Also packs are labelled as a AF062506 (25 mm length) but contained SF063006 (30 mm length).

Affected products

Profile Series 29 Hand File

Lot or serial number

00000018719
00000018723

Model or catalog number

SF062506
SF063006

Companies
Manufacturer
Dentsply International, Inc.
Dentsply Tulsa Dental Specialties
608 Rolling Hills Drive
Johnson City
37604
Tennessee
UNITED STATES