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Health product recall

Elements Gutta Cartridges (2016-11-17)

Starting date:
November 17, 2016
Posting date:
December 13, 2016
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-61402

Affected Products

  1. Elements Gutta Percha Cartridge 23 GA Medium Body
  2. Elements Gutta Percha Cartridge 23 GA Heavy Body

Reason

The following medical devices, Elements Gutta Percha Cartridge 23GA Medium Body and Elements Gutta Percha Cartridge 23GA Heavy Body are not licensed for sale in Canada.

Affected products

  1. Elements Gutta Percha Cartridge 23 GA Medium Body

Lot or serial number
  • 160805M
  • 160808M
Model or catalog number

972-2500

Companies
Manufacturer
Ormco Corporation
also trading as Sybronendo
1332 South Lone Hill Ave.
Glendora
91740
California
UNITED STATES

B. Elements Gutta Percha Cartridge 23 GA Heavy Body

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

972-2502

Companies
Manufacturer
Ormco Corporation
also trading as Sybronendo
1332 South Lone Hill Ave.
Glendora
91740
California
UNITED STATES