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Health product recall

TF Adaptive Gutta Percha Point Size SM3 50 pk (2016-02-09)

Starting date:
February 9, 2016
Posting date:
February 26, 2016
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-57286

Affected Products

TF Adaptive Gutta Percha Point Size SM3 50 pk

Reason

Outer package of device is identified as SM3 which matches inside product. The inner generic label is identified as ML3 which is incorrect.

Affected products

TF Adaptive Gutta Percha Point Size SM3 50 pk

Lot or serial number

GE15011637

Model or catalog number

815-1541

Companies
Manufacturer

Ormco Corporation

1332 South Lone Hill Avenue

Glendora

91740

California

UNITED STATES