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Health product recall

Endowel (2014-02-26)

Starting date:
February 26, 2014
Posting date:
April 7, 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-38671

Reason

Recall of all lots of product Endowel by manufactuer following the reclassification of device from Class I to Class II medical devices. Device Endowel was not licensed for sale in Canada due to change of class.

Affected products

Endowel

Lot or serial number

All lots

Model or catalog number

20586X

Companies

Manufacturer
Dentalez, Inc.
Stardental Division
1816 Colonial Village Lane
Lancaster
17601
Pennsylvania
UNITED STATES